The FDA has issued a warning letter related to BD Pyxis automated medication dispensing systems — technology that was part of its $12 billion CareFusion acquisition in 2015. The warning letter, dated Nov. 22 and posted on Dec. 17, involves inspections conducted in May at a former CareFusion facility in San Diego. It notes near […]
Regulatory/Compliance
BD to pay SEC $175M to settle Alaris investigation
BD (NYSE:BDX) announced that it reached an agreement with the SEC to resolve an investigation related to its Alaris system. The investigation relates to prior public disclosures and SEC reporting regarding Alaris, an infusion pump system. BD neither admits nor denies the findings of an SEC order related to those matters occurring more than four years […]
European court rules in favor of Abbott in Dexcom CGM patent spat
The Unified Patent Court in Paris sided with Abbott (NYSE:ABT) following a CGM patent infringement claim from Dexcom (Nasdaq:DXCM). Abbott and Dexcom are two leaders in the continuous glucose monitoring (CGM) space. They offer market-leading platforms, with Abbott’s FreeStyle Libre 3 and Dexcom’s G7 representing their latest-generation technologies. Dexcom requested that the court find infringement […]
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 […]
ViCentra wins CE mark for Kaleido insulin pump
ViCentra announced that it received CE mark approval for its Kaleido insulin pump under European Medical Device Regulation (EU MDR). Utrecht, The Netherlands-based ViCentra aims to deliver high-quality, user-friendly solutions for people with diabetes. The system last year launched in a hybrid closed-loop automated insulin delivery system that uses the Dexcom G6 CGM. Kaleido features pulse […]
