Senseonics (NYSE:SENS) is set to bring the longest-lasting continuous glucose monitor (CGM) to market following a major regulatory nod. Our sister site, Drug Delivery Business News, reports today that Senseonics received FDA clearance for its next-generation Eversense 365 CGM system. With the clearance, Eversense 365 becomes the world’s first 365-day CGM system, helping people with […]
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The 9 largest diabetes tech companies in the world
Diabetes technology comes in all shapes and sizes: insulin delivery systems, continuous glucose monitors and more. The companies that develop these technologies come in all shapes and sizes, too. Some focus entirely (or almost entirely) on solutions for people with diabetes. Others are much larger medtech firms that still have sizable business units that focus […]
The biggest stories from the American Diabetes Association (ADA) 2024 Scientific Sessions
The American Diabetes Association took to Orlando, Florida, the past few days for its 84th Scientific Sessions as optimism grows over diabetes tech. Topics covered included expanding technologies to the type 2 diabetes population (90% of people with diabetes), GLP-1 drugs, automation, broadening user bases and more. The usual big-hitters stepped up to the plate […]
The steps ahead for the Eversense implantable CGM platform
As Senseonics and Ascensia Diabetes Care looked for someone to help scale their CGM business, they turned to someone had only just retired. After close to eight years as Tandem Diabetes Care CCO, Brian Hansen notified the company of his decision to step down last August. His final day landed on Dec. 31, but he […]
Senseonics expects a Q4 launch for 365-day CGM, offers full-year outlook
Senseonics (NYSE:SENS) today shared its full-year financial outlook and laid out expectations for a new product launch this year. The Germantown, Maryland-based company said the FDA review of its next-generation, 365-day, once-per-week calibration Eversense implantable continuous glucose monitor (CGM) is advancing as planned. It expects the progress to enable 510(k) clearance in the near future […]
Senseonics post Q1 sales beat, submits 365-day iCGM to FDA
Senseonics (NYSE:SENS) shares ticked up after the market closed today on first-quarter results that came in ahead of the consensus sales forecast. Shares of SENS rose 8.1% to 41¢ apiece in post-market trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day down slightly. […]
Senseonics, Rimidi partner on remote diabetes monitoring program
Senseonics (NYSE:SENS) announced today that it entered into a strategic partnership with Rimidi to develop a remote patient monitoring program. Rimidi develops clinical management platforms for optimizing workflows, enhance patient experiences and hit objectives for chronic disease management. Together, the companies aim to develop the Eversense remote patient monitoring (RPM) program for use by healthcare […]
Senseonics wins integrated CGM designation from FDA, can work with insulin pumps
The FDA granted integrated CGM (iCGM) designation to the Eversense continuous glucose monitoring system from Senseonics (NYSE:SENS). With this designation, Eversense becomes the first fully implantable device in the category. Senseonics can now market the long-term CGM through the FDA’s de novo pathway. This establishes the special controls serving as a predicate device for future […]
Ascensia, Senseonics announce new CGM cost savings
Ascensia Diabetes Care and Senseonics today announced an extension to their Eversense Payment Assistance and Simple Savings (PASS) program. The program aims to help people in the U.S. access the Eversense E3 continuous glucose monitor (CGM) more affordably. It offers major savings for eligible individuals looking to experience the benefits of the long-term, implantable CGM. […]
FDA submission for 365-day CGM from Senseonics is ‘imminent’
Senseonics (NYSE:SENS) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast. The company also reported an “imminent” submission of its latest, longest-lasting continuous glucose monitoring (CGM) technology. Shares of SENS fell 3.5% to 69¢ apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of […]
Senseonics earns expanded Medicare coverage for long-term implantable CGM
Senseonics (NYSE:SENS) and Ascensia Diabetes Care today announced expanded Medicare coverage for the Eversense E3 CGM system. Medicare implemented Local Coverage Determinations (LCDs) providing access to implantable CGM for basal-only patients. It significantly expands access to Senseonics’ long-term (six months) implantable glucose monitor. The expansion for implantable CGMs includes all people with diabetes using insulin. […]
