The FDA said Fresenius Kabi told customers to remove its Ivenix large-volume infusion pumps from use for repair. This warning from the FDA comes as part of its Communications Pilot to Enhance the Medical Device Recall Program. The agency became aware of a potentially high-risk device issue and plans to keep the public informed on […]
Food & Drug Administration (FDA)
Cardinal Health recalls certain insulin syringe component packs
The FDA deemed a recall of Cardinal Health (NYSE:CAH) insulin syringe luer lock packs as type I, the most serious kind of recall. This recall relates to the company’s Monoject U-100 mL insulin syringe luer lock with tip cap soft pack (extended conical tip). The device is used to administer insulin under the skin (subcutaneous) or […]
Medtronic wins FDA nod for new InPen app to support launch with Simplera CGM
Medtronic (NYSE:MDT) announced today that it received FDA clearance for its new InPen insulin delivery system application. The app features missed meal dose detection and paves the way for the launch of the company’s smart multiple daily injection (MDI) system. That system includes the recently FDA-cleared next-generation Simplera continuous glucose monitor (CGM). Medtronic’s smart MDI […]
Medtronic to submit MiniMed 780G to FDA for type 2 diabetes in 2025, updates on patch pump
Medtronic (NYSE:MDT) has plans to submit its MiniMed 780G for an expanded indication from the FDA for type 2 diabetes in the near future. On the company’s second-quarter earnings call, Que Dallara, EVP and president of Medtronic Diabetes outlined the progress on that front. “We’ve finished enrollment [in a study of MiniMed 780G for type 2 […]
R3 Vascular wins FDA IDE for drug-eluting scaffold
R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold. Mountain View, California-based R3 Vascular designed Magnitude for treating below-the-knee (BTK) peripheral arterial disease (PAD). With the FDA granting IDE, it can now initiate the ELITE-BTK pivotal trial for the next-generation bioresorbable scaffold. R3 Vascular makes […]
FDA approves Abbott CGMs for use during medical imaging
Abbott (NYSE:ABT) announced today that the FDA said users can wear the FreeStyle Libre 2 and 3 CGMs during common imaging procedures. The FDA cleared the removal of the imaging contradiction for the continuous glucose monitors (CGMs) for procedures like X-rays, CT scans and MRIs. Abbott said it makes its systems the first and only […]
Insulcloud wins FDA nod to bring smart insulin pen cap tech to U.S.
Insulcloud today announced its strategic expansion into the U.S. following FDA clearance for its Insulclock CAP smart device. Madrid, Spain-based Insulcloud designed the device to monitor patient use of disposable insulin pens in real-time, increasing therapy adherence. The company said in a news release that the U.S. expansion underscores Insulclock CAP’s safety, efficacy and quality. […]
Dexcom submits 15-day CGM to FDA, beats Street in Q3
Dexcom (Nasdaq:DXCM) announced that, following the conclusion of the third quarter, it submitted its 15-day G7 CGM to the FDA. G7, the company’s latest-generation continuous glucose monitor (CGM), presently has approval for a 10-day wear time. Shares of DXCM were up slightly at the opening of trading today. Yesterday evening, Dexcom also reported third-quarter results […]
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic (NYSE: MDT) announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB). The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global Clinical Program […]
Medtronic recalls some MiniMed automated insulin delivery systems with battery issues
Medtronic (NYSE:MDT) today announced a voluntary recall warning of battery issues with its MiniMed 600 and 700 series insulin pumps. FDA deemed the recall Class I, the most serious kind. The medtech giant issued a field action starting on July 31, notifying customers to follow built-in alerts for battery status. Customers should contact Medtronic if […]
