The FDA issued a warning to consumers, patients, caregivers and providers around using certain technology to measure blood glucose. In the warning, the agency outlined the risks related to using smartwatches or smart rings for this purpose. Such devices may claim to measure blood glucose levels without piercing the skin. These devices are different from […]
Patient Monitoring
Tandem Diabetes Care launches Mobi mini automated insulin patch pump
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it kicked off the U.S. commercial launch of its Mobi insulin patch pump. The San Diego-based company says Mobi, which is fully controllable from a mobile app, is the world’s smallest durable automated insulin delivery (AID) system. It received FDA clearance for people with diabetes ages six and […]
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. […]
Dexcom says revenues could grow 20% in 2024
Dexcom (Nasdaq:DXCM) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast. Shares of DXCM fell 1.6% at $125 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day up 0.2%. The San Diego-based continuous […]
Insulet integrates Abbott FreeStyle Libre 2 Plus, Omnipod 5 in Europe
Insulet (Nasdaq:PODD) announced today that it received CE mark approval for the integration of the Abbott (NYSE:ABT) FreeStyle Libre 2 Plus with Omnipod 5. European approval covers the compatibility of Abbott’s glucose sensor with the Insulet automated insulin delivery system for individuals aged two years and older with type 1 diabetes. Currently, Omnipod 5 works […]
Former Tandem CCO joins Ascensia as president of CGM
Ascensia Diabetes Care parent company PHC Holdings and Senseonics announced today that Ascensia named Brian Hansen its president of CGM. Hansen’s appointment to the newly created role at the global distributor of Senseonics’ Eversense CGM went into effect today, Feb. 6. Responsibilities for Hansen include the global commercialization and growth of the Eversense system. The fully […]
Dexcom launches new ONE+ CGM system in Europe
Dexcom (Nasdaq:DXCM) announced today that it launched its latest continuous glucose monitor (CGM) system, the Dexcom ONE+. The San Diego-based company began rolling out the system in Spain, Belgium and Poland. It plans for a launch next week in the Netherlands, too. In some countries, the system replaces the previous-generation Dexcom One sensor. ONE+ uses […]
The top IVD and diabetes tech stories of 2023
Over the course of 2023, the medtech industry produced another impressive year of innovation, with news coming from a variety of spaces. Chiefly among those were diabetes technologies and in vitro diagnostics (IVDs). We saw regulatory nods, product launches, funds raised and mergers fall apart. Looking at those two spaces in particular, here are five […]
Abbott sees big opportunities in insulin pump connectivity
Just weeks after highlighting optimism around the Abbott (NYSE:ABT) Diabetes Care unit, company officials doubled down on their excitement. At the J.P. Morgan Healthcare Conference, CEO Robert Ford highlighted diabetes as a key area for near-term growth. On the company’s fourth-quarter earnings call today, he explained some of the driving factors behind the positive outlook. It […]
Samsung could battle Apple over non-invasive glucose monitors
Bloomberg reports that Samsung has eyes on developing non-invasive glucose monitoring technology, potentially pitting it against Apple. The report says the electronics company wants to develop continuous blood pressure checking along with glucose monitoring. It comes as part of an effort to incorporate health features in Samsung devices, like its Galaxy Ring, Bloomberg says. Hon Pak, […]