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 […]
Food & Drug Administration (FDA)
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 […]
Qnovia wins FDA nod for nicotine inhaler as smoking cessation therapy
Qnovia announced that the FDA cleared its investigational new drug (IND) application for the RespiRx smoking cessation inhaler (QN-01). RespiRx, a drug-device combination product, offers inhalable nicotine replacement therapy (NRT) to assist in the quitting of smoking. IND clearance allows Qnovia to initiate a Phase 1 trial in the U.S. to determine the pharmacokinetics, safety, […]
Fresenius Kabi recalls and removes some Ivenix infusion pump administration sets from market
The FDA issued a notice outlining a serious recall of Ivenix infusion pump administration sets from Fresenius Kabi. This recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type as it may cause serious injury or death. Fresenius Kabi recalled certain lots of the […]
Senseonics wins FDA nod for 365-day implantable CGM
Senseonics (NYSE:SENS) announced today that it received FDA clearance for its next-generation Eversense 365 CGM system. Eversense 365, an implantable continuous glucose monitor (CGM), becomes the world’s first 365-day CGM system, according to the company. Its indications cover people with type 1 and type 2 diabetes aged 18 years and older. The system also received clearance […]
