Dexcom (Nadsaq:DXCM) announced today that it received a warning letter from the FDA following inspections of two company facilities. The letter followed inspections of the company’s plants in San Diego and Mesa, Arizona. San Diego is where Dexcom’s headquarters is located, while the company last year decided to move manufacturing out of San Diego to […]
FDA
Baxter warns on certain infusion pumps with missing screws
The FDA today issued a notice warning of a potential high-risk issue with certain Baxter (NYSE:BAX) Spectrum infusion pump systems. This communication came as part of the FDA’s pilot to enhance its medical device recall program. It follows a letter from Baxter recommending that customers remove certain Spectrum pumps from where they are used or sold. […]
FDA clears Tandem Diabetes Care’s next-gen automated insulin delivery algorithm for type 2 diabetes
Tandem Diabetes Care (Nasdaq:TNDM) announced today that the FDA cleared its Control-IQ+ automated insulin delivery algorithm for people with type 2 diabetes. San Diego-based Tandem already has FDA clearance for its AID algorithm for type 1 diabetes. It now joins Insulet in offering AID technology for the type 2 population. Medtronic plans to file with […]
FDA warns of potential missed alerts with smartphone-connected diabetes devices
The FDA today issued an alert around a safety concern regarding diabetes devices that rely on smartphones to deliver critical safety alerts. Devices like continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems can use smartphones to deliver alerts. Users can configure alert settings through applications on their phone. The FDA received medical […]
Fresenius Kabi warns on Ivenix infusion pump valves
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 […]
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 […]
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 […]
