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 […]
FDA
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 […]
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 […]
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 […]
Embecta wins FDA clearance for disposable insulin patch pump
Embecta (Nasdaq:EMBC) announced today that it received FDA 510(k) clearance for its proprietary disposable insulin delivery system. The open-loop system is indicated for adults who require insulin to manage diabetes, including both type 1 and type 2 diabetes. It features a tubeless design with a 300-unit insulin reservoir, informed by feedback from people with type […]
