Baxter (NYSE:BAX) issued an urgent medical device correction for some Spectrum V8 and Spectrum IV infusion pumps in the U.S. The FDA later issued a notice identifying the recall as Class I, the most serious kind. Baxter recalled 22,769 devices in total. Affected pumps in the U.S. and Puerto Rico received upgrades to software versions […]
FDA
FDA clears updated BD Alaris infusion system after long-term commercial hold
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 […]
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 […]
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 clears automated insulin pump from Beta Bionics for type 1 diabetes
The FDA announced today that it cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software. FDA clearance covers the devices for people 6 years of age and older with type 1 diabetes. Combined with a compatible, FDA-cleared integrated continuous glucose monitor (iCGM), they form the iLet Bionic Pancreas. Using an […]
FDA approves ophthalmic spray from Eyenovia
Eyenovia (Nasdaq:EYEN) announced today that the FDA approved its Mydcombi treatment for use with the Optejet delivery device. New York-based Eyenovia designed Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. It marks the first approved fixed-dose combination of tropicamide and […]