JUVE-Patent reports that the Judicial Court of Paris again ruled in favor of Insulet (Nasdaq:PODD) in its patent battle with Medtrum. According to the report, the court sided with Insulet in a case regarding the company’s patent (EP 1 874 390). The ruling finds that Medtrum’s A6 and A7+ TouchCare insulin pump devices infringe the valid […]
Regulatory/Compliance
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. […]
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 […]
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. […]
Fresenius Kabi has a Class I Ivenix infusion pump recall
The FDA determined that a recall of the Fresenius Kabi Ivenix large-volume infusion pump is Class I, the most serious kind. This recall affects the LVP-0004 model of the Ivenix large-volume pumps. Fresenius Kabi distributed these systems between Oct. 1, 2021, and July 31, 2023. In total, the company recalled 938 devices in the U.S. […]
Dexcom submits new glucose sensor to FDA, expects launch this summer
Dexcom (Nasdaq:DXCM) announced that it submitted its new Stelo glucose sensor to the FDA for review at the end of last year. The continuous glucose monitor (CGM) maker designed Stelo specifically for people with type 2 diabetes who do not use insulin. San Diego-based Dexcom designed Stelo for a 15-day wear with a cash-pay option. […]
Embecta submits insulin patch pump for FDA clearance
Embecta (Nasdaq:EMBC) announced today that it submitted a 510(k) premarket filing to the FDA for its proprietary insulin patch pump. The Parsippany, New Jersey-based BD Diabetes spinoff developed a proprietary, disposable pump for people with type 2 diabetes. The company provided analysts with some details on the makeup of the open-loop system earlier this year. It […]
Medtronic wins CE mark for MiniMed 780G with Simplera Sync disposable, all-in-one CGM
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its MiniMed 780G system with Simplera Sync. Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM), eliminates the need for fingersticks and overtape. It features an improved user experience at half the size of previous Medtronic sensors with a simple, two-step insertion process. MiniMed […]
BD recalls more Alaris pumps due to compatibility issues with Cardinal Health syringes
The FDA determined that another recall of BD (NYSE:BDX) Alaris infusion pumps is Class I, the most serious kind. In the latest Alaris recall, the company cites compatibility issues with Cardinal Health Monoject syringes. The issue mainly relates to changes made to the products by Cardinal Health. It affects more than 1 million total devices. […]
FDA warning doesn’t affect Embecta syringes, company says
Embecta (Nasdaq:EMBC) says an FDA safety communication regarding certain plastic syringes has no impact on its own products. The FDA yesterday warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated with several Chinese […]