ivWatch announced today that it received a new FDA 510(k) clearance for its SmartTouch infusion detection and monitoring technology. Clearance covers the detection of iron sucrose extravasation events by the patented SmartTouch sensor and patient monitoring system. It expands the ivWatch system’s ability to better monitor and detect IV extravasations, improving IV safety across more […]
FDA
FDA issues warning letter to Medline over plastic syringes from China
The FDA followed up on a 2023 warning letter over unauthorized plastic syringes by issuing a warning letter to Medline. In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated […]
FDA approves Boston Scientific’s Agent drug coated balloon
Boston Scientific [WtwhTicker symbol=”BSX”](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Marlborough, Massachusetts-based Boston Scientific plans a U.S. launch for […]
FDA: Don’t use smartwatches, smart rings to measure blood glucose
The FDA issued a warning to consumers, patients, caregivers and providers around using certain technology to measure blood glucose. In the warning, the agency outlined the risks related to using smartwatches or smart rings for this purpose. Such devices may claim to measure blood glucose levels without piercing the skin. These devices are different from […]
Modular Medical submits next-gen insulin pump for FDA clearance
Modular Medical (Nasdaq:MODD) announced today that it submitted its next-generation MODD1 insulin pump to the FDA for 510(k) clearance. San Diego-based Modular Medical develops patented insulin delivery technologies, aiming to improve access to glycemic control. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem’s t:slim pump. […]
Fresenius Kabi has a Class I Ivenix infusion pump recall
The FDA determined that a recall of the Fresenius Kabi Ivenix large-volume infusion pump is Class I, the most serious kind. This recall affects the LVP-0004 model of the Ivenix large-volume pumps. Fresenius Kabi distributed these systems between Oct. 1, 2021, and July 31, 2023. In total, the company recalled 938 devices in the U.S. […]
Dexcom submits new glucose sensor to FDA, expects launch this summer
Dexcom (Nasdaq:DXCM) announced that it submitted its new Stelo glucose sensor to the FDA for review at the end of last year. The continuous glucose monitor (CGM) maker designed Stelo specifically for people with type 2 diabetes who do not use insulin. San Diego-based Dexcom designed Stelo for a 15-day wear with a cash-pay option. […]
Insulet has a Class I recall for the Omnipod 5 Android App
The FDA labeled a recall of the Insulet (Nasdaq:PODD) Omnipod 5 App for Android smartphones as Class I, the most serious kind. Insulet’s recall — a correction, not a product removal — affects software versions 1.1-1.2.3 for the Omnipod 5 automated insulin delivery system. It distributed the software between April 20, 2023, and Dec. 20, […]
PharmaSens submits insulin patch pump for FDA approval
PharmaSens announced today that it submitted an application for FDA approval for its Niia Essential insulin patch pump system. FDA submission follows the pump’s recent ISO 13485 certification for the Switzerland-based company. This encompassed the entire process of design, development, manufacturing and distribution for insulin infusion pumps and accessories. Niia Essential, the first of three […]
FDA approves Glaukos iDose TR glaucoma-treating drug delivery implant
Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant. The approval allows for one administration per eye of iDose TR (travoprost intracameral implant) 75 mcg. The indication for the prostaglandin analog covers the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle […]