MESA, AZ — September 27, 2023 — Myndshft Technologies, Inc., a pioneer in real-time medical benefits and automated prior authorization technology, proudly announces the launch of its revolutionary software platform for managing specialty medications under both medical and pharmacy benefits—the first of its kind in the industry. By simplifying and automating the complex processes involved in specialty medication management, the Myndshft platform bridges the gap between two traditionally isolated components of healthcare benefits, improving speed to therapy for patients.
One Platform. Unlimited Potential.
Healthcare providers, insurers, drug manufacturers, and pharmacies are plagued by the administrative complexities of drug management under disparate benefits. Likewise, patients face care delays, disjointed treatment journeys, higher costs of care, and poorer health outcomes. Recognizing this, Myndshft committed to expanding its suite of services to encompass both medical and pharmacy needs.
“We understand the challenges of siloed prior authorization processes. By developing a consolidated solution for drug management across both benefit types, Myndshft bridges long-standing gaps, enabling seamless data exchange and integrity between providers, PBMs, pharmacies and payers,” notes Ron Wince, founder and CEO of Myndshft.
The Myndshft platform tackles the administrative complexity that 88% of physicians rate as ‘high’ or ‘extremely high’ according to American Medical Association research.1 This optimizes medication management, breaking down barriers to affordability, and most importantly, enhancing the level of care patients receive.
The powerful Myndshft platform supports comprehensive benefits investigations for drugs under medical or pharmacy benefits, real-time benefits checks at the point of care, and intelligent automated prior authorization, offering improved cost transparency and care access to combat treatment abandonment. Moreover, in partnership with Atlas Health, the platform provides automated matching, enrollment, and reimbursement with patient assistance programs to mitigate the economic burdens often associated with specialty medications.
Myndshft Platform Advantages
- Eliminates the need for providers, pharmacists, and patients to navigate multiple systems, significantly decreasing administrative overhead and enhancing care efficiency.
- Improves cost transparency, enabling providers to effectively counsel patients on treatment options.
- Seamlessly integrates into existing healthcare workflows, creating efficiencies that free up human and financial resources.
- Adheres to current and emerging prior authorization regulations including gold carding, as well as state and federal policies and legislation.
“This announcement represents an exciting leap forward, not just for our organization, but for stakeholders across the healthcare spectrum,” says Wince. “By eliminating barriers to fast, equitable access to medications—regardless of whether they fall under medical or pharmacy benefits—Myndshft is creating momentum for value-based care models of the future.”
About Myndshft Technologies, Inc.
Myndshft began with a mission to enable value-based care by empowering healthcare providers and payers to drive down costs and increase revenue while achieving optimal patient care. Today, Myndshft is the only prior authorization platform that handles medications associated with medical and pharmacy benefits, delivering insights directly in any system of record. We do this by combining hands-free automation with Collective Healthcare Intelligence, a single source of truth for patients’ health and benefits information, providers’ clinical documentation, and payers’ plans and policies. Myndshft reduces manual work, eliminates duplication of effort, and shortens preauthorization cycle times so providers and payers can focus on patients, not paperwork.
For more information, visit www.myndshft.com.
1. Source: AMA Prior Authorization Physician Survey
Myndshft Media Contact
Name: Jennifer Royle-Jones
Email: jen@myndshft.com
Phone: (480) 718-2163 ext. 719
Contact Information
Name: Jennifer Royle-Jones
Email: jen@myndshft.com
Job Title: VP of Marketing & Revenue Operations
National Advertising Review Board Refers Smile Prep’s Clear Aligners Advertising to FTC After Compliance Review
New York, NY – September 27, 2023 – The National Advertising Review Board (NARB), the appellate advertising body of BBB National Programs, has referred advertising claims made by Smile Prep, LLC to the Federal Trade Commission (FTC) for review and possible enforcement action after the company declined to accept NARB recommendations to modify certain claims and disclosures on its website.
The challenged claims appeared on SmilePrep.com, which presents its reviews and rankings of clear aligner companies and their products and services as editorial content. Smile Prep has affiliate relationships with some, but not all, of the companies whose clear aligner products and services Smile Prep reviews and ranks on its website. Commissions from Smile Prep’s affiliate partners are its sole source of revenue.
In its decision (NARB Panel #310), the NARB Panel affirmed NAD’s decision (Case No. 7131) and recommended, among other things, that Smile Prep:
- Clearly and conspicuously disclose that the rankings, reviews, and product information for affiliate partners’ clear aligners on SmilePrep.com are advertising.
- Discontinue certain performance claims about the products and services of Smile Prep’s affiliate partners.
In its advertiser statement, Smile Prep stated that it disagreed with the NARB decision but would nevertheless make a good faith effort to comply with its recommendations. NARB opened a compliance inquiry based on concerns raised by the challenger, SmileDirectClub, LLC. In its Compliance Report, NARB found that Smile Prep had made a number of changes to its website in good faith but nevertheless was still not compliant.
Disclosure Recommendation
As part of its effort to comply with the NARB Panel’s recommendation Smile Prep revised its disclosure of affiliate relationships so that it appeared in a box at the top of each clear aligner review page stating, “Advertising Disclosure” in bold, followed by: “When you buy products and services through our links, we may earn commissions.”
NARB found that this disclosure is neither clear nor conspicuous, and therefore, Smile Prep has not complied with the decision in this respect.
Product Claims
In its decision, the NARB Panel recommended that Smile Prep discontinue the claim that “when it comes to customer service, Byte is the clear winner” and has “better customer support.” Although Smile Prep added qualifiers to these claims, NARB concluded that the addition of the phrases “it is our impression” and “we feel” did not change the nature of the message that the sponsor had engaged in a merits analysis of the clear aligner services being reviewed.
Further, NARB determined that modified language, which attributes performance claims to Byte, including “According to Byte,” and “According to Byte, the Hyper Byte can help provide a more comfortable aligner fit,” did not provide sufficient qualification. NARB also assessed 54 changes made by Smile Prep and found that the majority of the modified claims did not comply with the recommendation to discontinue certain aligner performance claims made by its affiliate partners on the ground that Smile Prep had not independently substantiated them.
For these reasons, NARB concluded that the customer service references and product performance of affiliate partner product claims do not comply with the NARB recommendations.
NARB requested Smile Prep’s agreement to make further modifications consistent with the analysis and comments in this Compliance decision.
In response, Smile Prep advised NARB that it believed that it was already in compliance with the decision and applicable laws and that it could not make all of the additional changes NARB had suggested. Smile Prep further stated that, in the event of a referral, it looked forward to working with the FTC to craft a meaningful and fair approach to the regulation of all affiliate review sites.
As Smile Prep declined to make additional modifications consistent with the analyses in the compliance review, NARB has referred the matter to the FTC for review.
All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive.
About BBB National Programs: BBB National Programs, a non-profit organization, is the home of U.S. independent industry self-regulation, currently operating more than a dozen globally recognized programs that have been helping enhance consumer trust in business for more than 50 years. These programs provide third-party accountability and dispute resolution services that address existing and emerging industry issues, create a fairer playing field for businesses, and a better experience for consumers. BBB National Programs continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-and-teen-directed marketing, data privacy, dispute resolution, automobile warranty, technology, and emerging areas. To learn more, visit bbbprograms.org.
About the National Advertising Review Board (NARB): The National Advertising Review Board (NARB) is the appellate body for BBB National Programs’ advertising self-regulatory programs. NARB’s panel members include 85 distinguished volunteer professionals from the national advertising industry, agencies, and public members, such as academics and former members of the public sector. NARB serves as a layer of independent industry peer review that helps engender trust and compliance in NAD, CARU, and DSSRC matters.
Contact Information
Name: Jennie Rosenberg
Email: jrosenberg@bbbnp.org
Job Title: Media Relations
Cognition Corporation Raises $6,000,000 to Accelerate Product Development and Customer Expansion in the Life Science Industry
Cognition’s continued growth enables medical device and pharmaceutical companies to bring safer products to market, while reducing time and costs.
Lexington, MA – September 26, 2023 – Cognition Corporation, the leader in SaaS-based product development and compliance solutions for the life science industry, today announced $6 million in funding, with a $5 million investment by Spring Lake Equity Partners which follows a $1 million investment by members of Cognition’s management team. The funding will be used to accelerate product development as well as increase sales and marketing programs to support Cognition’s rapid growth.
Cognition is shifting the data management landscape for medical device and pharmaceutical product development from a static, document centric approach to a dynamic, information-based data driven approach. Our solutions automate processes with built-in templates and work instructions. We leverage a structured data environment, that enables our customers to easily build relevant connections between data items, automatically create complex trace matrices, and export formatted documents instantly for regulatory submissions – saving both time and money.
“We are excited to secure this funding that will enable us to both accelerate product development and expand our customer base, and in the process help our customers save time and costs while bringing safer products to market faster,” said Gerald Wesel, Chairman and CEO, Cognition Corporation. “Spring Lake Equity Partners shares our vision for a new “structured data” paradigm for life sciences companies and recognizes Cognition’s potential as the leader in this space.”
“Cognition is well positioned to capture a significant portion of the market with their SaaS-based product development solutions. Their solutions leveraging structured data are unmatched in the industry and will change the way life science companies manage and submit their product development data,” said Bob Forlenza, Managing Partner, Spring Lake Equity Partners. “We are excited to partner with Gerald and the entire team at Cognition to achieve the company’s strategic goals.”
For more information about Cognition’s SaaS solutions for life science product development data, visit www.cognition.us.
For more information about Spring Lake Equity Partners visit https://springlep.com
About Cognition
Cognition Corporation specializes in product development and compliance solutions for the life sciences industries. For medical device professionals, Cognition offers a design controls software platform that helps meet regulations faster with real-time traceability, guided design controls, and change once, update everywhere functionality – turning manual and disconnected data into structured submissions that enable them to get to market faster.
Unlike other design controls solutions that simply replicate traditional documents and spreadsheets, Cognition takes a structured data approach combining risk with test and requirements data so you can easily build relevant connections between data items, automatically create complex trace matrices, and export formatted documents instantly – offering a more efficient and integrated solution.
We are shifting the data management landscape for medical device and pharmaceutical product development from a static, document-based approach to a dynamic, information-driven approach helping to streamline and alleviate the administrative burden of product development documentation. Further information about Cognition Corporation can be found at www.cognition.us.
About Spring Lake Equity Partners
Spring Lake Equity Partners is a Boston based firm investing in private technology companies. We seek to partner with great management teams to take their businesses to the next level, creating value for all stakeholders. Spring Lake strives to add value to our portfolio companies through active board participation, strategic planning, and accessing our network of contacts. To learn more please visit www.springlep.com.
Media Contact
Kristen Callahan
Director of Marketing
Cognition Corporation
+1 (781) 253 – 3388
kristen.callahan@cognition.us
National Advertising Division Recommends MacuHealth Discontinue or Modify Certain Claims for Several Brands of Eye Health Dietary Supplements
New York, NY – September 21, 2023 – In a challenge brought by Vision Elements, Inc., the National Advertising Division (NAD) of BBB National Programs recommended that MacuHealth, LP modify or discontinue certain claims for its dietary supplement products MacuHealth, MacuHealth Plus+, Vitreous Health, Vision Edge Pro, and TG Omega-3.
Of these supplements, MacuHealth, MacuHealth Plus+, and Vision Edge Pro, each contain a triple carotenoid formula (lutein, meso-zeaxanthin, and zeaxanthin) marketed to help consumers’ vision. VitreousHealth is marketed for managing eye floaters and TG Omega-3 Fish Oil is marketed for various benefits for eyes, heart, and brain health.
MacuHealth Product Claims
NAD determined that the studies submitted by MacuHealth indicating a growing body of research around supplementation with the cartenoids lutein, zeaxanthin, and mesozeaxanthin to effect macular pigmentation and visual performance are a poor fit to substantiate the challenged claims for various reasons, including that the studies were not conducted on MacuHealth as currently marketed to consumers.
Therefore, NAD recommended that MacuHealth discontinue any claims that its MacuHealth dietary supplements:
- Are clinically proven to rebuild or restore macular pigment, and
- Enhance vision or visual performance over a lifetime.
NAD also recommended that MacuHealth discontinue any claims that MacuHealth:
- “reduces inflammation in the retina,”
- “protects against harmful blue light”
- “improves photo-stress recovery and contrast sensitivity.”
- Contains a “patented blend of antioxidants [that] nourishes the eye to protect it against oxidative stress and disease.”
NAD noted that nothing in its decision prevents MacuHealth from making claims regarding the carotenoid formula of 10 mg lutein, 10 mg meso-zeaxanthin, and 2 mg zeaxanthin as long as they are narrowly tailored and properly supported.
MacuHealth Plus+ Claims
NAD found that the record did not contain sufficient evidence to substantiate the claim that MacuHealth Plus+ is “formulated for those diagnosed with Age-Related Macular Degeneration (AMD)” and recommended that the claim be discontinued. Among other things, NAD found that there were significant differences between the formulas marketed to consumers and those tested.
VitreousHealth Claims
To support its VitreousHealth product performance claims, MacuHealth relied on the Floater Intervention Study (FLIES). NAD found that although the FLIES was conducted on the VitreousHealth product and showed some promising results, it was not a good fit for the broad claims that VitreousHealth is “scientifically proven to significantly reduce floaters, enhance visual function and improve a patient’s quality of life” or can “reduce the severity of floaters.” Therefore, NAD recommended that these claims be discontinued, as well as several other challenged claims related to the outcomes of the FLIES.
TG Omega-3 Claims
NAD found that the articles and study provided by MacuHealth as substantiation did not support its TG Omega-3 product performance claims and recommended that the claims that TG Omega-3 “helps with joint pain, arthritis and other diseases” and “promotes eye, brain, heart and overall health” be discontinued.
NAD also noted that the challenged claims, “Both EPA & DHA have been studied and found to be beneficial for dry eye, and supplementation with omega-3 fatty acids is recognized as a key first step in the management of the disease and its symptoms” and “[B]ased on scientific studies, health care providers and optometrists are recommending patients increase their intake of Omega-3s” focus on product ingredients and not on the product as marketed to the consumer.
NAD found that the record did not contain sufficient evidence to support these claims and recommended that they be discontinued.
Improved Bioavailability Claims
NAD evaluated the study submitted by MacuHealth regarding its Micro-Micelle™ technology and determined that it is not competent and reliable scientific evidence to support the advertiser’s broad improved bioavailability claims. Therefore, NAD recommended that such claims be discontinued.
Natural & Gluten Free Claims
NAD recommended that MacuHealth discontinue claims that its MacuHealth product is an “all-natural formulation” and “a natural extract product,” as well as claims that its MacuHealth Plus+ is “clinically tested and gluten-free.”
During the proceeding the advertiser agreed to permanently discontinue many other challenged claims. Therefore, NAD did not review these claims on their merits.
In its advertiser statement, MacuHealth stated that it “believes that the challenged claims are thoroughly supported” and that it “strongly disagrees with the factual conclusions” reached in the decision, but nonetheless will comply with NAD’s recommendations.
All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive. Per NAD Procedures, this release shall not be used for advertising or promotional purposes.
About BBB National Programs: BBB National Programs, a non-profit organization, is the home of U.S. independent industry self-regulation, currently operating more than a dozen globally recognized programs that have been helping enhance consumer trust in business for more than 50 years. These programs provide third-party accountability and dispute resolution services that address existing and emerging industry issues, create a fairer playing field for businesses, and a better experience for consumers. BBB National Programs continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-and-teen-directed marketing, data privacy, dispute resolution, automobile warranty, technology, and emerging areas. To learn more, visit bbbprograms.org.
About the National Advertising Division: The National Advertising Division (NAD) of BBB National Programs provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and leveling the playing field for business.
Contact:
Jennie Rosenberg
Media Relations
BBB National Programs
press@bbbnp.org
National Advertising Division Refers Advertising by SBLA Beauty to the Federal Trade Commission for Review for Failure to Participate
New York, NY – September 21, 2023 – The National Advertising Division (NAD) of BBB National Programs has referred advertising claims made by SBLA Beauty, Inc. to the Federal Trade Commission (FTC) after the company failed to provide a substantive response to NAD’s inquiry.
The following are representative of the claims that served as the basis for this inquiry.
Express Claims
- “Try the first-ever eyelift at home, clinically proven to lift & smooth the eyelid in
minutes”
- “The Eye Lift Wand lifts and smooths the eyelids with the SBLA breakthrough
formula, including the patent-pending SBLA66Peptide™, a truly revolutionary
molecule.”
- “Smooths and lifts eyelid creases, hooded eyelids, lifts eyebrows and opens &
brightens the eyes.”
- “Visible results are immediate and with continuous daily use improve
progressively.”
- “Key Benefits:
o Opens the eye area by lifting the eyelids
o Lifts droopy eyelids
o Visibly smooths eyelid creases
o Tightens the skin of the entire eye area
o Diminishes crows feet and under-eye puffiness
o Improves skin texture and discoloration
o Builds collagen and regenerates skin cells”
Implied Claim:
- The Eye Lift Wand immediately delivers results akin to an eye lift medical procedure.
Despite repeated outreach attempts, SBLA Beauty did not submit a substantive response to NAD’s inquiry or participate in the self-regulatory process. Per NAD/NARB Procedures, NAD has referred this matter to the FTC for review and possible enforcement action.
All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive. This release shall not be used for advertising or promotional purposes.
About BBB National Programs: BBB National Programs, a non-profit organization, is the home of U.S. independent industry self-regulation, currently operating more than a dozen globally recognized programs that have been helping enhance consumer trust in business for more than 50 years. These programs provide third-party accountability and dispute resolution services that address existing and emerging industry issues, create a fairer playing field for businesses, and a better experience for consumers. BBB National Programs continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-and-teen-directed marketing, data privacy, dispute resolution, automobile warranty, technology, and emerging areas. To learn more, visit bbbprograms.org.
About the National Advertising Division: The National Advertising Division (NAD) of BBB National Programs provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and leveling the playing field for business.
Contact Information
Name: Jennie Rosenberg
Email: jrosenberg@bbbnp.org
Job Title: Media Relations
Monitoramento de Terceiros
A LexisNexis | Nexis Solutions apresentou a Classificação de Risco do QSA Gráfico, nova funcionalidade do produto que visa mitigar riscos reputacionais tanto de empresas quanto de pessoas físicas, realizando a análise e fazendo a classificação de entidades e indivíduos em três níveis de risco: baixo, médio e alto. O novo recurso do produto foi mostrado durante o Fórum ESG Novas Tendências, um evento que reuniu profissionais, líderes e especialistas para debater as principais tendências globais em ESG (Ambiental, Social e Governança) em junho/2023, na sede da Firjan, no Rio de Janeiro.
Como funciona a Classificação de Risco:
A classificação de risco é baseada em uma configuração prévia, categorizando diversas fontes de listas restritivas, incluindo situação cadastral da RFB, PEPs, Listas de Sanções (nacionais e internacionais), embargos do Ibama e outros órgãos, dados do Portal da Transparência, ONU, entre outras. É possível até mesmo subir suas próprias listas privadas (para verificação de possível conflito de interesses) e visualizar notícias negativas na mídia.
Caso uma empresa ou terceiro tenha algum apontamento nessas listas, a ferramenta fornece uma análise detalhada, apresentando um dashboard com informações como situação cadastral pública, classificações, sócios e suas respectivas situações. Trata-se de uma análise completa, capaz de realizar uma varredura abrangente do terceiro parceiro. “Você automatiza o processo de checagem de terceiros otimizando seu tempo e certificando- se de que seu processo de gerenciamento de risco está sempre em dia”, destaca um especialista da LexisNexis.
Sobre a importância do Serviço de Gerenciamento de Riscos de Terceiros, foi ressaltado que o objetivo da funcionalidade de classificação de riscos do QSA Gráfico é ser uma ação preventiva, educativa e de melhoria contínua, colaborando para que todas as empresas envolvidas evoluam para o mais alto grau de governança e segurança.
A LexisNexis apresentou as novidades durante o painel “ESG, due diligence e tecnologia”, um dos momentos mais aguardados do Fórum ESG Novas Tendências. A LexisNexis | Nexis Solutions foi patrocinadora Master do evento e marcou presença com sua equipe de especialistas.
Contact Information
Name: Aline Santos
Email: aline.felipedossantos@lexisnexis.com
Job Title: Business Developer
Cognition® Corporation Announces Compass® PRO: A Flexible SaaS Solution Purpose-Built for Medical Device Product Development
Compass PRO is the latest addition to Cognition’s Compass family, empowering medical device manufacturers to efficiently and effectively manage their design controls data by providing a solution to grow with their business.
Lexington, MA – September 20, 2023 – Cognition Corporation, a leader in Software-as-a-Service (SaaS) solutions for medical device and pharmaceutical product development, today announces Compass PRO, the latest in their product portfolio designed specifically for medical device companies. Compass PRO provides trusted guided compliance functionality with flexible customization to meet business needs and processes. Compass PRO is a SaaS solution that streamlines the design control process for medical device product development. It is purpose-built to interconnect large amounts of diverse data, including risk, requirement, and test data, while automatically applying quality processes across all company functions and user actions. The solution will be available for demonstrations starting in October.
Leveraging a structured data model, Compass PRO enables companies to confidently bring products to market faster by:
- Integrating risk, requirement, and test management data into a single, connected tool;
- Facilitating the easy reuse of data through data libraries;
- Streamlining usability analysis in line with IEC 62366-1:2015;
- Supporting compliance with ISO 13485:2016, 21 CFR 820.30, and ISO 14971:2019;
- Enabling data export for storage in a document management system;
- Providing effortless reporting on traceability; and
- Customizing/extending functionality to meet business needs and processes.
“We have taken 20+ years of best practices and industry knowledge and poured them into our Compass product family. This gives us the ability to provide medical device companies a ‘quick start’ in managing their product development data using our guided compliance solutions with built-in templates. The release of Compass PRO is the next step in empowering medical device companies to deliver safer products to market faster by enabling them to align precisely with their business needs and processes,” said Ben Higgitt, Product Line Manager, Compass/Compass PRO. “What truly sets Compass PRO apart is its ability to provide seamless and robust connectivity between risk, requirement, and test data. In the fast-evolving world of medical device product development, staying ahead is essential, and Compass PRO is designed to guide companies toward success.”
Compass PRO provides a single solution for managing design controls data. Its key features include:
- A unified environment: integrating risks, requirements, and tests to maintain consistency and linkages within the product development environment.
- Design and development: step-by-step implementation of rigorous processes to support design control with a strong emphasis on requirement management to comply with 21 CFR 820.30 and ISO 13485/EU MDR.
- Flexible risk environment: risk management not only requires precision but also adaptability; Compass PRO was developed specifically to ensure compliance with changing standards.
- Usability analysis: built-in templates to support the usability engineering process defined in IEC 62366-1:2015 including Use Specification, Function and Task Analysis, Use Scenario Analysis, Correct Use Analysis, and Use Error Analysis.
- Reusability: leveraging centrally managed libraries for Hazards and Harms, streamlining the accessibility and consistency of this critical data.
- Integrated reporting and analysis: built-in reporting and analysis for easy custom report generation, allowing users to tailor reports to their specific needs—giving companies a comprehensive view of the most pivotal factors in their design controls process.
- Effortless reporting on traceability: supporting the most complex trace matrices, accommodating tens of thousands of items and traces effortlessly. These trace matrices offer clear data visualization and evidence of alignment between inputs and outputs while also highlighting intricate connections among risk, requirements, and test data.
- Easy document export: exporting documents is straightforward and fast in Compass PRO. Documents export submission-ready with no post-processing required.
“The entire Cognition team is thrilled to announce Compass PRO, a real game-changer for the medical device industry. With Compass PRO, we’ve put customization at the forefront, allowing our customers to tailor the software to meet their unique business needs and processes while maintaining all the functionality our medical device customers rely on,” said Gerald Wesel, Chairman & CEO, Cognition Corporation. “We believe Compass PRO will empower medical device companies to take their product development data to new heights, and we can’t wait to see the positive impact it will have on the industry.”
Compass PRO has multiple use cases to help medical device companies bring safer products to market faster. These include speeding time to market, addressing remediation, creating Design History Files (DHF), and supporting compliance with standards and regulations like ISO 14971, 21 CFR 820.30, IEC 62366-1, and ISO 13485/EUMDR. It provides unmatched connectivity between risk, requirement, and test data with a 360-degree view of a company’s product development project and with real-time and historic traceability for the most informed planning, development, and impact analysis.
For more information on Cognition’s Compass PRO solution, click here.
About Cognition
Cognition Corporation specializes in product development and compliance solutions for the life sciences industries. For medical device professionals, Cognition offers a design controls software platform that helps meet regulations faster with real-time traceability, guided design controls, and “change once, update everywhere” functionality, turning manual and disconnected data into structured submissions that enable them to get to market faster.
Unlike other design controls solutions that simply replicate traditional documents and spreadsheets, Cognition takes a structured data approach, combining risk with test and requirements data so you can easily build relevant connections between data items, automatically create complex trace matrices, and export formatted documents instantly—offering a more efficient and integrated solution.
We are shifting the data management landscape for medical device and pharmaceutical product development from a static, document-based approach to a dynamic, information-driven approach, helping to streamline and alleviate the administrative burden of product development documentation. Further information about Cognition Corporation can be found at www.cognition.us.
Media Contact
Kristen Callahan
Director of Marketing
Cognition Corporation
+1 (781) 253 – 3388
kristen.callahan@cognition.us
LexisNexis Launches Nexis Diligence+™
Nexis Diligence+™ pairs advanced technology and an unmatched collection of global data to empower organizations to mitigate risk and conduct due diligence at scale.
NEW YORK— Sept 14, 2023—Today, LexisNexis® launched a new due diligence solution that is setting a higher standard for assessing risk at scale—Nexis Diligence+™. The new platform pairs advanced technology with access to an unmatched collection of global data to help organizations quickly identify threats and make decisions with confidence.
Nexis Diligence+ helps companies mitigate reputational, regulatory, financial and strategic risks by connecting them with the critical intelligence needed to vet customers, suppliers, partners, and other third-parties. Users can conduct enhanced due diligence, map relationships and affiliations, search for negative news and ESG-related coverage, and check against sanctions to build thorough, 360-degree risk assessment profiles while maintaining an auditable trail.
“When it comes to due diligence research, it’s important to have high standards—especially for evaluating risk,” said Dani McCormick, Vice President, Product. “Within Nexis Diligence+, business professionals will find the tools they need to conduct searches at scale, efficiently identify business risks, make more informed decisions and earn maximum responsible profit.”
The platform’s high-volume, scalable searching capabilities were specifically designed to save time and streamline the often-complicated and time-consuming research process—just one of the many features that make Nexis Diligence+™ one of the most comprehensive due diligence tools on the market:
- Customizable entity view: Users can customize and tailor their risk-scoring methodologies to reflect their company’s goals and best practices. Default preferences can be set at an organizational level to ensure process consistency across all users.
- High-volume, scalable searching capabilities: Upload unlimited entities and generate results exponentially From there, users access a condensed view of the data to annotate, refresh, set alerts for, and export.
- Insight-filled reports: Quickly uncover insights and trends to inform business decisions or future research with powerful visualization tools and reports.
- Unrivaled collection of news and data: Access to a full text global news archive, with more than 38,000 sources. Available datasets also include: sanctions & watchlists, PEPs, state-owned enterprises, ESG ratings, company reports & filings, biographies, legal data, and US public records.
- Intuitive user experience: A simple, intuitive interface available in multiple languages makes it easy to efficiently vet and monitor third parties.
To learn more about how the Nexis Diligence+ platform can supercharge your approach to risk assessment, please visit www.lexisnexis.com/diligence-plus
About LexisNexis Legal & Professional
LexisNexis® Legal & Professional provides legal, regulatory, and business information and analytics that help customers increase their productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 150 countries with 11,300 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers.
Media Contact
Leela Bozonelis
LexisNexis | Nexis Solutions
leela.bozonelis@lexisnexis.com
5 Cenários Mais Comuns de Comunicação de Crise
Bianca Minguci fornece informações sobre como lidar com cada um dos problemas que surgem nas redes sociais que podem afetar imagem da marca Por Bianca Minguci – 04/09/2023
A presença nas redes sociais atualmente é essencial para as empresas sobreviverem e prosperarem. No entanto, a priorização das pegadas digitais também traz consigo um alto custo, pois diversos erros potenciais estão relacionados à publicação de conteúdo, interação com os consumidores e até mesmo à gestão de relações públicas (RP).
Felizmente, a maioria das armadilhas potenciais para crises de RP e redes sociais pode ser categorizada, facilitando a previsão e preparação para esses problemas. Neste artigo, exploramos cinco dos cenários mais comuns que podem levar uma empresa a acionar suas práticas de comunicação de crise, além de fornecer informações sobre como lidar com cada um deles.
Comunicação de crises em tempo real nas redes sociais
As crises mais comuns nas redes sociais podem ser desencadeadas por problemas nas postagens das empresas ou por consumidores que fazem reclamações públicas sobre a marca. Um conteúdo supostamente engraçado pode se tornar ofensivo, levando a empresa a uma situação delicada. Por outro lado, relatos negativos de consumidores podem viralizar e prejudicar a imagem da marca.
Para prevenir problemas nesse cenário, é crucial monitorar ativamente as redes sociais e contar com uma ferramenta de análise social para rastrear menções à empresa e acompanhar o sentimento do público. Em caso de problemas, a empresa deve agir rapidamente com uma declaração pública bem redigida que reconheça o erro e prometa correções futuras. O apoio da alta direção é fundamental para transmitir credibilidade ao público.
Disseminação de notícias falsas e conteúdo enganoso
Com o avanço da inteligência artificial, conteúdos e notícias falsas têm se multiplicado na internet, dificultando a distinção entre informações verdadeiras e falsas para o público. Esse cenário representa uma ameaça significativa para as empresas, pois notícias negativas e enganosas podem afetar a reputação da marca e a confiança dos consumidores.
Nesse contexto, é crucial contar com ferramentas de monitoramento de mídia para identificar notícias falsas ou enganosas. Uma vez detectadas, a empresa deve agir prontamente para corrigir a situação e, se necessário, tomar medidas legais contra os responsáveis pela disseminação de informações falsas.
Ex-funcionários compartilhando experiências negativas
Crises de comunicação também podem surgir quando ex-funcionários compartilham publicamente experiências negativas relacionadas ao ambiente de trabalho, como casos de violência ou discriminação. Essas histórias podem prejudicar significativamente a reputação da empresa.
Para evitar agravamento da situação, a empresa deve monitorar regularmente menções à sua marca em notícias e redes sociais. Quando essas situações ocorrerem, é fundamental que a empresa emita um pedido de desculpas público e se comprometa efetivamente a combater quaisquer violações legais ou ofensivas no local de trabalho. Em casos mais graves, detalhar as medidas tomadas para resolver o problema pode ajudar a restaurar a confiança do público.
Falta de diversidade e inclusão
A falta de transparência ou posicionamento falso em relação à diversidade e inclusão pode gerar grandes problemas para uma empresa, especialmente quando há contradição entre o que a empresa declara apoiar e a realidade de sua equipe.
Para evitar crises nesse cenário, é importante que a empresa se posicione claramente em relação às suas práticas de diversidade e inclusão. Se críticas públicas surgirem, é fundamental esclarecer como a empresa planeja melhorar sua diversidade nos próximos meses e divulgar um comunicado público com ações concretas.
Violação de Segurança Cibernética
Empresas que lidam com informações sensíveis devem estar preparadas para enfrentar crises decorrentes de violações de segurança cibernética. Caso ocorra uma violação, é necessário entrar em contato imediato com as pessoas afetadas e fornecer orientações sobre como proteger suas informações.
Além de notificar os consumidores, é crucial que a empresa se posicione publicamente sobre as ações tomadas para evitar futuras violações e reconstruir a confiança com o público.
Planos de comunicação de crise para cada situação
Independentemente do setor, todas as empresas devem ter um plano de comunicação de crise para lidar com imprevistos. A ação rápida e eficaz é essencial para reconstruir a confiança pública. Um plano detalhado para cada cenário permite que a equipe de RP e mídias sociais saiba como agir e evitar novos equívocos.
Para se preparar adequadamente, é fundamental monitorar regularmente o nome da marca na internet. O uso de ferramentas de inteligência de mídia pode automatizar esse monitoramento, fornecendo relatórios e alertas pontuais para que a equipe de RP esteja sempre atualizada sobre a percepção pública da empresa e possa responder rapidamente a qualquer crise.
Em resumo, as empresas devem estar cientes desses cinco cenários mais comuns de comunicação de crise e preparadas para agir prontamente em cada situação. Monitorar ativamente as redes sociais e utilizar ferramentas de inteligência de mídia são estratégias-chave para minimizar os problemas da era digital e preservar a reputação da marca.
*Por Bianca Minguci é Business Development Manager LATAM na LexisNexis
Contact Information
Name: Bianca Minguci
Email: bianca.minguci@lexisnexis.co.uk
Job Title: BDM
Introducing the first Stars of the MICHELIN Guide Colorado
- Five restaurants receive a MICHELIN Star in inaugural selection
- Colorado bursts onto scene with four MICHELIN Green Stars
- Nine Bib Gourmand, plus four Special Awards, also awarded
- 44 total restaurants, 15 cuisine types reflected in state Guide
DENVER, Sept. 12, 2023 — The MICHELIN Guide officially has made its debut in Colorado with five One-MICHELIN-Star establishments and four MICHELIN Green Star restaurants.
Brutø and The Wolf’s Tailor each were awarded one MICHELIN Star, plus a MICHELIN Green Star.
The full selection, including Bib Gourmand restaurants and Recommended eateries, totals 44 restaurants. Chefs and restaurant teams were honored Tuesday night at the Mission Ballroom in Denver.
“This is a proud moment for Colorado and for the MICHELIN Guide, with five MICHELIN- Starred restaurants highlighting the state’s debut selection of restaurants,” said Gwendal Poullennec, the International Director of the MICHELIN Guides. “It’s quite an impressive feat for a debut selection to include so many MICHELIN Green Stars. Our famously anonymous inspectors were wowed by these restaurants’ high-quality, local ingredients, sourced seasonally and sustainably. It’s a very exciting time for the culinary community here, and we feel the momentum growing.”
Here are the new One-MICHELIN-Star restaurants, with inspector notes from each (Inspectors’ comments in full on the MICHELIN Guide website and mobile app):
One MICHELIN Star
Beckon (Denver; Contemporary cuisine)
More than just a name, it’s an ethos at this ambitious RiNo dining room from Chef Duncan Holmes where staff warmly welcome you. Once inside this Scandi-cool space, diners pull up a chair at the 18-seat counter facing the kitchen where a focused team is hard at work. The multicourse contemporary tasting menu rotates quarterly (think harvest-themed in the fall). This kitchen offers far from typical dishes. Seared quail breast with a confit leg is spot on, especially when sided by creamed kale made with sunflower seeds and a quail reduction.
Bosq (Aspen; Contemporary cuisine)
At this singular enclave, Chef Barclay Dodge and his team are executing seasonally inspired cooking that focuses on foraging, fermenting and local farms. The menu format allows diners to customize their own tasting of four or more courses. From hand-picked spruce tips to butter from locally sourced cooperative dairy cows, this is a concept that pays attention to details — even ingredients from farther afield, like lobster from New England, gets a hit of local flavor from being grilled over juniper wood.
Brutø (Denver; Mexican/Contemporary cuisine)
Chef Michael Diaz de Leon runs the show here, where the team takes a serious approach to locality and seasonality, not only in the produce but also the grains, which they mill or nixtamalize in-house. The mastery of the hearth as the primary cooking implement makes this operation special, and it infuses each of the tasting menu’s courses with distinct notes. The menu, which is Mexican at its core, has a clear narrative, and is perhaps best displayed in lamb prepared two ways — as a street-style taco and ground lamb leg kushiyaki with a quenelle of mole chichilo.
Frasca Food and Wine (Boulder; Italian cuisine)
All are treated as special guests here, where Chef Ian Palazzola’s cooking is Italian, but in a hyper-specific way: It’s the food of the northeast Italian region of Friuli Venezia Giulia. You’ll find pasta and seafood on the prix fixe and tasting menus, but Slavic and Alpine elements also appear. Focused and distinct, the menu might showcase a lesser-known part of Italy, but the ingredients are clearly Coloradan. The plates are beguiling with a minimal, straightforward approach, as in cjalson, half- moon fresh spinach pasta pockets filled with an English pea and potato purée.
The Wolf’s Tailor (Denver; Contemporary cuisine)
With culinary stylings as singular as its name, this charmer stands apart from the pack. Chef Taylor Stark shepherds a creative multicourse menu that abounds with personality, boasting a unique, genre-defying style that draws variously from Nordic, Italian and East Asian cuisines, but nonetheless feels focused and cohesive. Although the menu shifts throughout the year to explore different themes, diners will find a common thread in cooking that highlights ingredients while displaying technical precision and harmonious flavors, with fermentation a frequent motif.
MICHELIN Green Star
Blackbelly Market (Boulder; American cuisine)
Initiatives: full utilization of every ingredient and animal, most of which are butchered in-house; sourcing from local ranches and farms that apply natural practices to everything they cultivate; herbs and flowers for plates grown on property.
Bramble & Hare (Boulder; American cuisine)
Initiatives: organic farm with 70 acres growing more than 250 varieties of vegetables, herbs and grain, which is ground into flour on a stone mill; an acre of chamomile for restaurant use; 360 acres of pasture for raising heritage sheep and pigs.
Brutø (Denver; Mexican/Contemporary cuisine)
Initiatives: zero-waste ethos; fermentation program to create umami-based ingredients; house-milled grains grown in Colorado; hyper-local sourcing; partnership with Zero Foodprint to help reduce carbon footprint and carbon emissions.
The Wolf’s Tailor (Denver; Contemporary cuisine)
Initiatives: zero-waste mentality; local apple cider vinegar project; recycling bread waste into sourdough gochujang; contract farming to grow heirloom wheat for flour on organic, regeneratively farmed land; on-site pollinator garden; certified sustainable foraging program.
Bib Gourmand
The MICHELIN Guide Inspectors identified nine restaurants to award the Bib Gourmand designation, which recognizes eateries for great food at a great value: AJ’s Pit Bar-B- Q, Ash’Kara, Basta, The Ginger Pig, Glo Noodle House, Hop Alley, La Diabla Pozole y Mezcal, Mister Oso and Tavernetta.
MICHELIN Special Awards
In addition to the Bib Gourmand and Stars, the Guide announced four Special Awards:
The MICHELIN Guide Ceremony is presented with the support of Capital One.
Hotels
The restaurants join the MICHELIN Guide selection of hotels, which features the most unique and exciting places to stay in Colorado and throughout the world.
Each hotel in the selection has been chosen by MICHELIN Guide experts for its extraordinary style, service, and personality — with options for all budgets — and each can be booked directly through the MICHELIN Guide website and app. The selection for Colorado features the state’s most spectacular hotels, including upscale outdoor campsites like Collective Vail, standouts from our “Plus” collection like the Source Hotel and the Crawford Hotel in Denver, refurbished motels like Amigo Motor Lodge, and rehabilitated wilderness ghost towns like Dunton Hot Springs.
The MICHELIN Guide is a benchmark in gastronomy. Now it’s setting a new standard for hotels. Visit the MICHELIN Guide website, or download the free app for iOS and Android, to discover every restaurant in the selection and book an unforgettable hotel.
The 2023 MICHELIN Guide Colorado selection:
Colorado’s 2023 MICHELIN-Starred restaurants
Colorado’s 2023 MICHELIN-Green-Starred restaurants
Colorado’s 2023 Bib Gourmand restaurants
Colorado’s 2023 Recommended restaurants
About Michelin North America, Inc.
Michelin, the leading mobility company, is working with tires, around tires and beyond tires to enable Motion for Life. Dedicated to enhancing its clients’ mobility and sustainability, Michelin designs and distributes the most suitable tires, services and solutions for its customers’ needs. Michelin provides digital services, maps and guides to help enrich travel and make them unique experiences. Bringing its expertise to new markets, the company is investing in high-technology materials, 3D printing and hydrogen, to serve a wide variety of industries — from aerospace to biotech. Headquartered in Greenville, South Carolina, Michelin North America has approximately 23,000 employees and operates 34 production facilities in the United States and Canada. (michelinman.com)
About Capital One
At Capital One we’re on a mission for our customers – bringing them best-in-class products, rewards, service, and experiences. Capital One is a diversified bank that offers products and services to individuals, small businesses and commercial clients. We use technology, innovation, and interaction to provide consumers with products and services to meet their needs. Through Capital One Dining and Capital One Entertainment, we provide our rewards cardholders with access to unforgettable experiences in the areas they’re passionate about, including dining, music and sports. Learn more at capitalone.com/dining and capitalone.com/entertainment.
For more information, contact:
Andrew Festa Michelin North America
andrew.festa@michelin.com
Devon Gunn Capital One
devon.gunn@capitalone.com
Phone: 571-308-4762
Contact Information
Name: Andrew Festa
Email: andrew.festa@michelin.com
Job Title: Press Officer