Beta Bionics (Nasdaq:BBNX) recently disclosed the receipt of a warning letter from the FDA following an inspection. An FDA inspection of the company’s Irvine, California, facility from June 9, 2025, through June 26, 2025, led to the warning letter. In the letter, the FDA outlined deficiencies in the automated insulin delivery system maker’s response letters […]
Diabetes
Dexcom adds enhanced smart meal logging feature to Stelo CGM
Dexcom (NSDQ:DXCM) announced today that it plans to launch an advanced AI-enabled enhancement to its Stelo over-the-counter CGM. The new enhancements to the continuous glucose monitor (CGM) aim to transform how users understand their glucose health. Dexcom said it hopes to help Stelo users achieve their long-term health goals through the updates. It plans to […]
Abbott receives FDA warning letter related to FreeStyle Libre CGMs
Abbott (NYSE:ABT) is facing an FDA warning letter alleging quality system regulation violations related to FreeStyle Libre CGM production. The FDA issued the letter on Jan. 23 and made it public today, Feb. 3. It relates to an inspection of Abbott’s Alameda, California, facility from Oct. 14, 2025, through Oct. 23, 2025. According to the […]
Medtronic earns Medicare, FDA wins for MiniMed 780G with Instinct sensor, including for type 2 diabetes
Medtronic (NYSE:MDT) today announced three U.S. milestones expanding access to its MiniMed 780G automated insulin delivery system. The company announced Medicare access for MiniMed 780G paired with the Instinct sensor made by Abbott, FDA clearance for the pairing for insulin-requiring type 2 diabetes and FDA clearance for the system’s use with ultra rapid-acting insulins. Medtronic […]
LifeScan CEO Valerie Asbury retires from glucose management company
LifeScan CEO Valerie Asbury said on social media today that she is retiring from the glucose management technology developer. On LinkedIn, Asbury said she plans to step away after more than 15 years at the company. “Today marks my last day at LifeScan, and while it is bittersweet, I am deeply grateful for the remarkable […]
MyLife Diabetes Care completes transition to independent company
MyLife Diabetes Care announced that its transition into an independent company has now been formally completed. In August, Ypsomed announced that it completed the sale of its diabetes care business to TecMed AG. With this sale, the company transitioned MyLife from a business unit into a standalone company. This follows a recent medtech trend, with […]
Lilly to build $3.5B injectable medicine, device manufacturing plant in Pennsylvania
Eli Lilly (NYSE:LLY) today announced plans to invest more than $3.5 billion to build a new manufacturing plant in Pennsylvania. The site, in Lehigh Valley, will serve as the company’s newest injectable medicine and device manufacturing facility. Indianapolis-based Lilly plans to produce next-generation weight-loss therapies there, including retatrutide, a first-in-class investigational GIP, GLP-1 and glucagon […]
Senseonics wins CE mark for Eversense 365 year-long CGM
Senseonics (NYSE:SENS) announced today that its Eversense 365 continuous glucose monitor (CGM) system received CE mark approval. Germantown, Maryland-based Senseonics received FDA clearance for Eversense 365 in September 2024. It launched the year-long CGM implant with its global distribution partner, Ascensia Diabetes Care, the following month. It has since taken over full commercial activity for […]
Glucotrack picks up new patents for continuous blood glucose monitor
Glucotrack (Nasdaq:GCTK) announced today that it received new U.S. patents for its continuous blood glucose monitoring (CBGM) platform. The U.S. Patent and Trademark Office (USPTO) issued Patent Nos. US 12,453,494, US 12,458,257 and US 12,458,258. These patents strengthen the company’s competitive position and intellectual property protection as it advances its CBGM system toward commercialization. Glucotrack’s […]
ViCentra picks former Insulet leader as VP, global marketing
Insulin patch pump maker ViCentra announced today that it appointed Reman McDonagh as its VP, global marketing. The Utrecth, the Netherlands-based company said McDonagh’s appointment further strengthens its leadership team as it scales commercial execution across Europe. It also bolsters the company amid preparations for its next-generation Kaleido system, including expected European and U.S. launches. McDonagh’s […]
