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 […]
Diabetes
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 […]
Fractyl Health goes the IPO route
Fractyl Health — developer of medtech and gene therapies to reverse diabetes and obesity — began trading on the Nasdaq today under the symbol GUTS. Lexington, Massachusetts–based Fractyl Health priced its 7,333,333 shares of common stock at $15 per share, enabling it to bring in about $110 million from the IPO. The company expected the […]
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. […]
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 […]