Month: September 2023

• Two restaurants earn a MICHELIN Star for the first time
• Toronto receives its first-ever MICHELIN Green Star
• 21 Bib Gourmand, plus four special awards, also unveiled
• 82 total restaurants, 28 cuisine types reflected in selection

 

TORONTO, Sept. 27, 2023 — Two restaurants, Kappo Sato and Restaurant 20 Victoria, joined the exclusive list of MICHELIN-Starred eateries in Canada, as the 2023 MICHELIN Guide Toronto was announced Wednesday night.

Overall, the anonymous MICHELIN Guide inspectors awarded Stars to 15 restaurants, with Sushi Masaki Saito remaining atop that list with two MICHELIN Stars. The 2023 selection comprises 82 restaurants and 28 types of cuisine. Chefs and restaurant teams were honored during a ceremony at HISTORY in Toronto.

Frilu, which retained its one MICHELIN Star, and White Lily Diner, which earned a 2023 Bib Gourmand, were awarded the city’s first MICHELIN Green Stars in recognition for their leadership in sustainable gastronomy.

“Since the inaugural selection in Toronto last year, we have seen and felt the momentum grow in this culinary community,” said Gwendal Poullennec, the International Director of the MICHELIN Guides. “The passion, encouragement and determination has been evident, and we see the fruit of that labor today. We are very pleased to welcome Kappo Sato and Restaurant 20 Victoria into the family of MICHELIN-Starred restaurants. The famously anonymous Guide inspectors were also inspired by the commitment to sustainable gastronomy at Frilu and White Lily Diner.”

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

Kappo Sato (Japanese cuisine)

Unlike the quiet ceremony of a sushi omakase or the formal structure of a kaiseki, this freewheeling tasting is driven solely by Chef Takeshi Sato, who swims in familiar culinary waters on his own terms. The room is a constant blur of motion thanks to a young team that hurries about preparing multiple courses at once. Sato is their seasoned guide, as he moves with intention, ever masterful with a knife, and works with an impressive bounty of ingredients, most of which are flown in from Japan. Soulful dashi broths weave in and out of view alongside clever courses like tempura fried mackerel with shiso or seared toro nigiri with Japanese green onions.

Restaurant 20 Victoria (Contemporary cuisine)

On a quiet stretch of downtown Toronto, Chef Julie Hyde is making her talents known in this tiny-but-mighty restaurant that captured the city’s heart the day it opened. Top-notch local produce, pristine seafood and refined sauce work make for a delicious trifecta on a seasonal tasting menu that boasts originality in spades. Recent highlights included smoked beets with oyster cream as well as grilled fish with beurre blanc and eel crumble. The dimly lit dining room is elegantly easy-going, as Hyde and her small team work with laser-like focus from a kitchen that’s simultaneously always in use and always pristine.

MICHELIN Green Star

Frilu (Contemporary cuisine)

Owner-established Willowolf Farm uses no-till methods to grow fruits and vegetables for Frilu to use throughout the seasons. Chef John-Vincent Troiano hand-picks produce every morning to ensure a truly sustainable farm-to-table experience. A composting program uses all kitchen waste to enrichen the farm’s soil. Canadian ingredients, bought from local markets and farmers, are used throughout the year.

White Lily Diner (Creative cuisine)

Their organic, no-till farm and greenhouses supply the diner (and more than 15 other restaurants) with produce. They raise chickens to supply the diner with eggs. Only hand tools are used on the farm. Insect netting and greenhouses mitigate insects and disease. An orchard was recently planted and is being cultivated.

Bib Gourmand

The MICHELIN Guide inspectors added four restaurants to the Bib Gourmand list, which recognizes eateries for great food at a great value: BB’s, Sunnys Chinese, Tiflisi and White Lily Diner.

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 Toronto and throughout the world. Each hotel 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 Toronto features the city’s most spectacular hotels, including sustainability pioneers like 1 Hotel Toronto, standouts from the “Plus” collection like the Hazelton and the SoHo, cutting-edge boutiques like Ace Hotel and the Drake, and dependable luxury stalwarts like the Ritz-Carlton.

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 Toronto selection:

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

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

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

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