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 […]
Technology
Tandem stock dips after hours on Q4 misses, 10% growth expected in 2024
Tandem Diabetes Care (Nasdaq:TNDM) shares took a hit after hours on fourth-quarter results that came up short of the consensus forecast. Shares of TNDM fell 8% at $20.74 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 0.2%. […]
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. […]
Embecta beats The Street in Q1, raises guidance as insulin pump development moves along
Embecta (Nasdaq:EMBC) shares took a hit this morning despite Street-beating first-quarter results and increased 2024 guidance. Shares of EMBC fell 7.8% at $16.37 apiece as the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — opened today relatively even. The Parsippany, New Jersey-based BD Diabetes […]
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 […]
Modular Medical picks up new insulin pump patent for mobile device connectivity
Modular Medical (Nasdaq:MODD) announced recently that it received a new U.S. patent to pair its insulin pump with a mobile device. The company picked up U.S. Patent 11,817,197 B2 for the stream-lined pairing of a pump to a mobile device. Just last month, it submitted its 90-day MODD1 pump to the FDA for 510(k) clearance. […]