Feb 22,2024 TOP STORY

New Challenger Onboard? Syai Health Brings the New Fashion to CGM Experience & Chronic Disease Management

Singapore-based biotech company, Syai Health, abbreviated for "Sychronise + AI", secured significant funding from leading investors like AstraZeneca plc and Xiaomi Corporation for its in-house developed AI-empowered medical devices. Syai Health is prepared to broaden the horizon and reshape the CGM experience with its user-centric product lineup empowered by AI integration. Syai's CGM device pairs with a user-friendly app and cloud-based data solutions that allow patients to track, retrieve, and share real-time data or reports with their healthcare providers or families for more comprehensive care.

FUNDING FUNDING ROUND

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Feb 13,2024

Tandem Diabetes Care Launches Tandem Mobi, the World’s Smallest, Durable Automated Insulin Delivery System

Tandem Diabetes Care announced the United States commercial launch of its new Tandem Mobi, less than half the size of the t:slim X2 insulin pump, durable automated insulin delivery system for people living with diabetes. Users can wear Tandem Tobi wherever they want on their body with a lightweight adhesive sleeve, and is compatible with the Dexcom G6 Continuous Glucose Monitoring (CGM) System. Additional CGM sensor integrations are planned, including Dexcom G7 in the second quarter of 2024, followed by integration with the Abbott FreeStyle Libre 3 sensor.

PRODUCT

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Feb 13,2024

Medicare Coverage Significantly Expanded for the Eversense E3 CGM System

Ascensia Diabetes Car, and Senseonics Holdings announced that Medicare has significantly expanded access to the Eversense E3 CGM System, with the implementation of Local Coverage Determinations providing access to implantable CGM for basal only patients, by the first three Medicare Administrative Contractors (MACs). Medicare coverage has been expanded for implantable CGMs to include all people with diabetes using insulin, removing the previous requirement for multiple insulin administrations per day. The new policy has also been updated to cover non-insulin-users who have a history of problematic hypoglycemia. Noridian, Palmetto and National Government Services (NGS) are the first three MACs to publish final local coverage determinations (LCD). The earliest MAC expansion becomes effective on February 25, 2024 and the companies expect the remaining MACs to finalize their expansion in the near future.

PRODUCT

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May 23,2019

LifeScan deal challenges Abbott, Dexcom for CGM market

LifeScan, a former Johnson & Johnson unit, has partnered with Sanvita Medical to enter the continuous glucose monitor (CGM) market in North America and select European countries, aiming to address the growing demand for CGM systems. Facing competition from established players like Abbott and Dexcom, LifeScan plans to design CGM devices that integrate with its OneTouch Reveal blood sugar management apps. The move is seen as a strategic response to offset market pressures and declining sales of OneTouch products. Dexcom and Abbott have already secured significant market shares, generating billion-dollar sales with their CGM devices. LifeScan's challenge lies in differentiating its CGM offering amid strong competition.

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Feb 06,2024

Dexcom Launches Dexcom One+ Bringing Powerful, New Diabetes Management Technology to More People

Dexcom announced the launch of their latest CGM system, Dexcom ONE+. The system is available now in Spain, Belgium, and Poland and launches next week in the Netherlands. Additional countries in Europe, the Middle East and Africa will be announced in the following months. In some countries Dexcom ONE+ replaces the previous generation Dexcom ONE sensor. The company also incorporated feedback from both end users and healthcare professionals when building Dexcom ONE+, ensuring an easy-to-use, highly effective, CGM experience for people treating their Type 1 or Type 2 diabetes with insulin.

PRODUCT

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Feb 06,2024

PHC Holdings Corporation and Senseonics Announce Appointment of Brian Hansen as President of CGM at Ascensia Diabetes Care

PHC Holdings Corporation, the parent company of Ascensia Diabetes Care along with Senseonics Holdings, Inc., announced that diabetes industry veteran Brian Hansen has been appointed to the newly created role of President of CGM at Ascensia Diabetes Care, effective February 6, 2024. Ascensia is the exclusive global distributor of the Eversense® E3 CGM system developed and manufactured by Senseonics. Mr. Hansen will be responsible for the global commercialization and growth of the innovative Eversense CGM, currently available in the U.S. and select European markets.

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Feb 07,2024

Insulet Announces CE Mark Approval of Omnipod® 5 Integration with Abbott FreeStyle Libre 2 Plus Sensor

Insulet Corporation announced it has received CE mark approval under the European Medical Device Regulation for the added compatibility of the Abbott FreeStyle Libre 2 Plus sensor with Insulet’s Omnipod 5 Automated Insulin Delivery System for individuals aged two years and older with type 1 diabetes. Insulet expects Omnipod 5 integration with the Abbott FreeStyle Libre 2 Plus sensor to be available first in the United Kingdom and Netherlands in a phased launch in the first half of 2024, with additional markets to follow.

REGULATORY CE MARK

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Feb 02,2024 TOP STORY

How Kakao Healthcare's latest AI-powered mobile diabetes app works

Kakao Healthcare has unveiled its latest AI-driven mobile diabetes management app. Called PASTA (Personalised, Accessible, Supportive, Tech-enabled, and Affordable), the app currently links to two CGM devices: CareSens Air by local manufacturer i-SENS and Dexcom's G7. The app will also pair with the Mallya smart cap for insulin pens by the second quarter. Once the CGM device is linked, the app automatically displays details about the user's blood sugar in real-time via Bluetooth. It also allows users to record their meals, exercise, insulin doses, and medication. The app features vision AI that automatically provides information about nutrition, calories, and food types of their meals. Another feature is a handy summary report of the user's blood sugar reading with indicators pointing out which ones are good and bad. These summaries are also made available for sharing with the user's family. It can also provide a guide to managing blood sugar levels and creating healthy lifestyle habits. Meanwhile, Kakao Healthcare developed Pasta Connect Pro, a dashboard for doctors where they can check their patients' blood sugar trends and lifestyle changes in near real time. It is planned to be linked with hospital EMRs to provide convenience of data input to staff and patients.

PRODUCT

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Jan 31,2024 TOP STORY

Trinity Biotech Announces Entry into a Letter of Intent with Bayer for a Joint Partnership to Launch a CGM Biosensor Device in China and India

Trinity Biotech announced that it has entered into a non-binding Letter of Intent with Bayer for the launch of a Continuous Glucose Monitoring biosensor device in China and India. This Letter of Intent is related to Trinity’s recently announced acquisition of the CGM assets of Waveform Technologies, Inc. Both parties intend to negotiate a definitive agreement under the framework set by the Letter of Intent in the coming months. The China Joint Partnership intends to leverage Bayer's significant and well-established presence in the Chinese healthcare market, particularly in diabetes, and is intended to lead to the launch of a low cost of care, high quality, CGM device designed to increase affordability and accessibility of diabetes care. To date, CGM use in India is not widespread, but has been trending higher recently with increasing awareness about self-care. Bayer Pharma India has a strong presence in the diabetes market with brands like Kerendia® and Glucobay®.

COLLABORATION PARTNERSHIP

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Jan 31,2024 TOP STORY

Trinity Biotech Announces Acquisition of the CGM Assets of Waveform Technologies

Trinity Biotech announced it has entered into a definitive agreement to acquire the biosensor and Continuous Glucose Monitoring assets of privately held Waveform Technologies for $12.5 million in cash, 9 million American Depositary Shares of the Company and additional contingent consideration. “We plan to begin our journey in a de-risked manner, by using a CGM device that has already received regulatory approval as our platform sensor technology, which we intend to redesign and optimize for broad adoption and then evolve this platform technology to measure and analyse other valuable biomarkers and related datapoints." said John Gillard, Chief Executive Officer. Waveform, a developer of novel and proprietary new technologies for diabetes care, received a CE Mark for its Cascade CGM in 2019, which has since been commercially available in Europe. Waveform will no longer sell the Cascade device and Tinity Biotech will not sell that device in its current form. Trinity intends to design a next generation CGM sensor using Waveform’s platform technology and has secured additional funding from Perceptive Advisors for the next stage of the product’s development. Under the Amended Term Loan, an additional $22 million of funding has been made available to the Company, with $12.5 million being used to acquire the Waveform assets. The remaining $9.5 million is available for general corporate purposes including for the further development of the CGM and biosensor technologies.

COLLABORATION MERGERS & ACQUISITION

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