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Diabetes

FDA identifies serious recall for Dexcom CGM mobile apps

September 15, 2025 By Sean Whooley

Dexcom One+ CGM phone and receiver (1)

The FDA identified a recent recall of smartphone apps for Dexcom (Nasdaq:DXCM) continuous glucose monitors (CGMs) as the most serious type. This recall involves correcting certain devices through a software update. It does not involve removing them from where they are used or sold. Serious recalls can lead to serious injury or death without correction. […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Technology Tagged With: Dexcom, FDA

Insulet eyes Middle East expansion as McEvoy talks future plans

September 12, 2025 By Sean Whooley

Insulet Omnipod 5 worn on the back of an arm

Insulet (Nasdaq:PODD) has its eyes on future expansion in new geographies, according to some of its leading executives. Speaking during the Wells Fargo Conference last week (transcribed by Investing.com), President and CEO Ashley McEvoy and EVP and CFO Ana Maria Chadwick outlined expansion plans for its automated insulin delivery technology, particularly in the Middle East. […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Technology Tagged With: Insulet

Court dismisses several claims against Dexcom in securities lawsuit

September 11, 2025 By Sean Whooley

Dexcom updated Logo

A California judge has dismissed several claims against Dexcom (Nasdaq:DXCM) officials related to alleged misrepresentation of sales efforts. Judge Robert S. Huie of the Southern District of California ruled in the consolidated action, which combines three securities class actions against the San Diego-based continuous glucose monitor (CGM) maker. Huie’s judgment denied Dexcom’s motion to dismiss […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Legal News, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Dexcom

NHS offers artificial pancreas to pregnant women with type 1 diabetes in the UK

September 8, 2025 By Sean Whooley

Ypsomed MyLife Loop CamDiab pregnant woman with diabetes

The NHS announced a first-of-its-kind initiative in England, offering automated insulin delivery systems for pregnant women with diabetes. NHS said its local healthcare systems can offer enhanced hybrid closed-loop systems, also known as artificial pancreases, to women with type 1 diabetes who are pregnant or planning a pregnancy. This way, they can effectively manage their […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Technology, Women's Health Tagged With: NHS

The top Dexcom stories of 2025 so far

September 8, 2025 By Sean Whooley

Dexcom Stelo glucose monitor

At Dexcom (Nasdaq:DXCM), one of the leaders in continuous glucose monitoring (CGM), innovation continues to roll on. The company has been expanding its offerings with next-generation sensors, over-the-counter offerings and improved wear times. It has also introduced new AI features and enhanced connectivity that make diabetes management easier. Dexcom’s CTO Girish Naganathan will speak about the future […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: Dexcom

Orange Biomed takes next step to bringing A1C test device to market

September 5, 2025 By Sean Whooley

Orange Biomed rapid a1c

Orange Biomed announced a major milestone on its path to bringing a pocket-sized A1C analysis device to the market. The Seattle-based company received Good Manufacturing Practice (GMP) certification for in vitro diagnostic medical devices from Korea’s Ministry of Food and Drug Safety. This enables it to scale production of the pocket-sized portable diabetes testing device. […]

Filed Under: Business/Financial News, Diabetes, Diagnostics, Food & Drug Administration (FDA), Patient Monitoring, Technology Tagged With: Orange Biomed

Tandem wins nod in Canada for smartphone app to control t:slim X2 automated insulin pump

September 4, 2025 By Sean Whooley

Tandem Diabetes Care Tandem Mobile app (1)

Tandem Diabetes Care (Nasdaq:TNDM) announced today that Health Canada authorized its t:slim mobile application for Android and iPhone users. Authorization allows users of the t:slim X2 automated insulin delivery system to deliver a bolus from their compatible smartphone. They can also wirelessly upload pump data to the cloud-based Tandem Source platform. Tandem — one of the largest […]

Filed Under: Diabetes, Drug-Device Combinations, Regulatory/Compliance, Technology Tagged With: Tandem Diabetes Care

Dexcom to lay off more than 300 employees in California

September 4, 2025 By Sean Whooley

Dexcom updated Logo

Dexcom (Nasdaq:DXCM) filed with the state of California to confirm plans to lay off more than 300 employees in San Diego. The leading continuous glucose monitor (CGM) maker filed a Worker Adjustment and Retraining Notification (WARN) notice in California on Aug. 27. California officials processed the filing on Aug. 28 and the headcount cut goes […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: Dexcom

Senseonics to take over commercial efforts for Eversense 365 from Ascensia

September 3, 2025 By Sean Whooley

Senseonics Ascensia Eversense 365 Product image

Senseonics (NYSE:SENS) announced today that it entered into an agreement with Ascensia Diabetes Care to take over commercialization efforts for its products. The companies entered into a mutually executed memorandum of understanding. This agreement transitions all commercialization and distribution of the Eversense 365 long-term implantable continuous glucose monitor (CGM) and future products from Ascensia to […]

Filed Under: Business/Financial News, Diabetes, Distribution, Drug-Device Combinations, Featured, Implants, Patient Monitoring, Technology Tagged With: Ascensia Diabetes Care, Senseonics

ViCentra prepares for big commercial push with its Kaleido automated insulin patch pump

September 3, 2025 By Sean Whooley

ViCentra Kaleido on arm

For ViCentra CEO Tom Arnold, the journey to lead a developer of insulin delivery technologies was a personal one. A veteran of more than two decades in medtech, he only took over the corner office at the Dutch insulin patch pump maker in February. However, his focus on diabetes goes back much further than last […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Technology Tagged With: ViCentra

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