Mar 26,2024

Nouvelle levée de fonds de 15 millions d’euros pour Diabeloop qui annonce la nomination de François Miceli au poste de Président et Directeur Général

Diabeloop announced a major step in its growth with a €15 million fundraising round and the appointment of François Miceli as its new President and CEO. The funds will support the company's development, particularly in accelerating revenue growth for its DBLG1 closed-loop system and preparing the launch of DBLG2, a smartphone-integrated algorithm compatible with both Android and iOS.

FUNDING FUNDING ROUND
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Aug 09,2024 TOP STORY

Health2Sync Announces Strategic Partnership with Sanofi in South Korea

Health2Sync announced today that the partnership with Sanofi has extended its footprints to South Korea, along with the launch of SoloSmart, an integrated digital solution developed by Sanofi to help facilitate personalized care for patients with diabetes. This partnership marks a milestone for the first data integration of SoloSmart with a single chronic disease management App in Korea. It brings forth the fourth country in which the two companies collaborated, namely Taiwan, Japan, Egypt, and now Korea. To provide comprehensive daily diabetes management and a better user experience, Health2Sync recently included Korean in its well-recognized patient app and the “Patient Management Platform.” The Health2Sync app has 1.3 million registered users worldwide as of August 2024, and the company is looking forward to creating a real-time monitoring ecosystem in diabetes management by leveraging various devices, including continuous glucose monitoring (CGM), blood glucose meters (BGM), exercise and sleep trackers, and smartwatches such as Fitbit.

COLLABORATION PARTNERSHIP

#connected device

#mobile app

#insulin pen

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Aug 27,2024

GLUCOTRACK ANNOUNCES NEW VICE PRESIDENT OF CLINICAL OPERATIONS

Glucotrack, a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced today that Sandie Martha has joined the Company as Vice President of Clinical Operations. Ms. Martha brings over 20 years of clinical research experience in both medical technology and drug development, leading all aspects of clinical trials including protocol development and execution, clinical site training and monitoring, and regulatory submissions. Ms. Martha brings an impressive track record of strategic planning and successful delivery of clinical trials to quickly advance products through the clinical lifecycle. She previously served as Vice President of Clinical Affairs at Glysens, where she led planning and execution for domestic and international clinical trials for an implantable continuous glucose monitor.

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Aug 26,2024

FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes

the U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older. An interoperable automated glycemic controller is software that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).

REGULATORY FDA

#closed loop

#cgm

#insulin pump

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Aug 08,2024

CMS finalizes reimbursement rule for breakthrough devices

The Centers for Medicare & Medicaid Services (CMS) has issued a final procedural notice for its Transitional Coverage for Emerging Technologies (TCET) program, aimed at expediting Medicare coverage of novel medical devices. This new pathway will streamline the review process, allowing manufacturers to engage with CMS earlier and bridge evidence gaps through targeted studies. Key features of TCET include pre-market engagement with CMS, allowing device manufacturers to submit non-binding letters of intent up to 18-24 months before FDA approval. Devices under TCET can retain temporary national coverage while evidence is generated, with an indefinite coverage period expected to last at least five years. The program is a response to the long delays that Breakthrough Devices face between FDA authorization and CMS coverage, which has averaged over five years.

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Sep 04,2024 TOP STORY

Beta Bionics Announces Partnership with Abbott to Integrate the iLet Bionic Pancreas with the FreeStyle Libre 3 Plus iCGM

Beta Bionics announced they are working to integrate Abbott’s glucose sensing technology with the iLet Bionic Pancreas automated insulin delivery system. The iLet will soon connect to Abbott’s FreeStyle Libre 3 Plus continuous glucose sensor, where readings every minute will help the iLet calculate insulin doses. The iLet Bionic Pancreas will be the first AID integration of FreeStyle Libre 3 Plus available in the United States. The integration will launch in Q4 2024 and will offer people a new way to manage their type 1 diabetes that will fit seamlessly into their lives. 

COLLABORATION PARTNERSHIP

#connected device

#closed loop

#cgm

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Sep 05,2024 TOP STORY

ABBOTT'S LINGO™ CONTINUOUS GLUCOSE MONITOR FOR HEALTH AND WELLNESS NOW AVAILABLE IN THE U.S.

Abbott announced U.S. availability of Lingo™, the company's first continuous glucose monitoring system available without a prescription. The Lingo system includes a biosensor and a mobile app designed for consumers who want to improve their overall health and wellness. Lingo is based on Abbott's FreeStyle Libre continuous glucose monitoring technology, now used by more than 6 million people with diabetes globally. Abbott's consumer biowearable, Lingo, is available for consumers 18 years and older not on insulin. Lingo tracks glucose in real-time and provides personal insights and coaching to help people build healthy habits, retrain their metabolism and improve their overall well-being. The biosensor can be worn on the back of the arm for up to 14 days.

PRODUCT

#cgm

#mobile app

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Aug 01,2024

Teladoc Health stock drops amidst Q2 2024 earnings report

Teladoc Health, a New York-based virtual care company, saw its stock price drop from $9.44 to $8.10 after reporting a 2% revenue decrease in Q2 2024 to $642.4 million. The BetterHelp segment's revenue fell by 9%, while the Integrated Care segment saw a 5% increase. The company reported a significant net loss of $837.7 million, up from $65.1 million in Q2 2023, but adjusted EBITDA rose by 24%. Teladoc withdrew its 2024 financial outlook and its three-year projections. New CEO Chuck Divita aims to improve company performance despite challenges in the BetterHelp segment. The company also faces a potential class-action lawsuit over alleged mismanagement of BetterHelp's marketing. Despite these challenges, Teladoc formed a new partnership with Brightline to enhance mental healthcare for children and families.

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Aug 08,2024

State of digital health investment, part 2: LBMC

Matt Cybulsky of LBMC discussed current trends in digital health investment, noting a slowdown from the peak investment period of two years ago due to macroeconomic pressures. Despite this, there's renewed interest in AI and its potential to enhance healthcare efficiency and patient outcomes. Cybulsky emphasized the need for robust business plans and realistic market predictions. He highlighted common issues in AI, including the "black box" problem and the practical value of data analytics. Cybulsky also noted investor fatigue with AI hype but stressed its continued importance in scaling and innovation.

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Aug 06,2024

State of digital health investment interview with Andreessen Horowitz

Daisy Wolf from Andreessen Horowitz (a16z) discussed the digital health investment landscape, noting that U.S. startups raised $5.7 billion in early 2024, indicating a strong sector outlook. Wolf highlighted the transformative potential of AI in streamlining healthcare, advised founders to align with investor interests, and emphasized that despite market fluctuations, capital is always available for standout ideas. The pandemic accelerated digital health's integration with traditional healthcare, and Wolf remains optimistic about the sector's future.

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