Sequel Med Tech announced today that its partner, DEKA R&D, won FDA 510(k) clearance for its automated insulin delivery (AID) system. The twist system, powered by Tidepool, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. Sequel will market […]
Regulatory/Compliance
Smiths Medical recall affects nearly 86,000 syringe pumps with software issues
Smiths Medical issued a recall for its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions. The ICU Medical unit issued the recall as a correction — not a product removal. It affects 85,961 pumps distributed between Aug. 9, 2022, and Aug. 15, 2023. Smiths Medical initiated the infusion syringe pump […]
FDA clears first over-the-counter CGM from Dexcom
Dexcom (Nasdaq:DXCM) announced today that the FDA cleared its Stelo glucose biosensor that does not require a prescription. This marks the first FDA clearance for a continuous glucose monitoring (CGM) technology for over-the-counter use. In January, Dexcom first announced that it submitted the new Stelo sensor to the FDA for review at the end of last […]
FDA approves Boston Scientific’s Agent drug coated balloon
Boston Scientific [WtwhTicker symbol=”BSX”](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Marlborough, Massachusetts-based Boston Scientific plans a U.S. launch for […]
Report: Insulet trumps Medtrum again in French patent spat
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 […]
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. […]