BD (NYSE:BDX) announced today that the FDA granted 510(k) clearance for its updated Alaris infusion system. Shares of BDX closed out Friday evening priced at $264.84 each. They ticked up significantly after market close on the back of the Alaris news, rising 5.9% to $280.40 apiece. Clearance enables both remediation and a return to full […]
Food & Drug Administration (FDA)
FDA approves drug-coated balloon for BPH symptoms from Urotronic
Urotronic announced that the FDA approved its Optilume BPH catheter system for to alleviate urinary symptoms caused by BPH. Minneapolis-based Urotronic designed Optilume as a minimally invasive surgical therapy. It combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel. This treats lower urinary tract symptoms secondary to BPG (benign prostatic […]
FDA updates guidance on paclitaxel-coated devices, determines no link to late mortality risk
The FDA issued healthcare providers updated guidance for certain warning language with paclitaxel-coated devices that treat PAD. These peripheral arterial disease (PAD)-treating devices produced data that does not support an excess mortality risk. Specifically, the FDA’s guidance eliminates the need for certain warning language in the device labeling. An FDA panel in 2019 determined that […]
Better Therapeutics wins FDA nod for type 2 diabetes digital therapeutic
Better Therapeutics (Nasdaq:BTTX) announced that the FDA authorized its AspyreRx prescription digital therapeutic for diabetes. AspyreRx, formerly BT-001, provides cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The prescription-only digital therapeutic (PDT) underwent review through the FDA de novo pathway. The company submitted an FDA de novo request in September 2022 for […]
FDA clears Tandem Diabetes Care’s Mobi durable automated insulin pump
Tandem Diabetes Care (Nasdaq:TNDM) announced today that the FDA cleared its Tandem Mobi automated insulin delivery (AID) system. Clearance covers people with diabetes ages six and up, expanding the Tandem portfolio of products. San Diego-based Tandem says Mobi, which is fully controllable from a mobile app, is the world’s smallest durable AID system. Mobi features […]
Koru Medical submits infusion system for FDA 510(k) clearance
Koru Medical Systems (Nasdaq:KRMD) announced today that it submitted its Freedom60 infusion system for FDA 510(k) clearance. The submission covers the use of the Freedom60 infusion system with the Hizentra 50 mL prefilled syringe. In January, Koru inked a development agreement with a manufacturer of subcutaneous immunoglobulin therapy (SCIg). The deal sought to garner regulatory […]
CellTrans wins FDA approval for first cell therapy that treats type 1 diabetes
The FDA announced that it approved the Lantidra allogeneic pancreatic islet cellular therapy developed by CellTrans to treat diabetes. It marks the first approval of a donor pancreatic cellular therapy — made from deceased donor pancreatic cells — to treat type 1 diabetes. The approval covers adults with type 1 diabetes who prove unable to […]
FDA approves Surmodics SurVeil drug-coated balloon
Surmodics (Nasdaq:SRDX) announced today that the FDA granted approval for its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodis may now market and sell SurVeil in the U.S. for percutaneous transluminal angioplasty. Use follows appropriate vessel preparation or de novo or restenotic lesions in femoral and popliteal arteries. These arteries feature reference vessel diameters of […]
ICU Medical recalls certain infusion pump replacement batteries
The FDA issued a notice determining that the recall of ICU Medical (Nasdaq:ICUI) infusion pump batteries is Class I, the most serious kind. ICU Medical initiated a recall of replacement batteries for certain infusion systems on March 22, 2023. The recall affects its Plum 360, Plum A+ and Plum A+3 infusion systems. The infusion systems […]
FDA approves another nasal spray for treating opioid overdose
The FDA approved Opvee nalmefene hydrochloride nasal spray for the emergency treatment of opioid overdoses from Opiant Pharmaceuticals. Approval covers the treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This market the first such authorization for this type of spray in healthcare and community use. […]
