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 […]
Food & Drug Administration (FDA)
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. […]
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 […]
MiniMed 780G a ‘monumental improvement,’ Medtronic Diabetes head says
It’s been a long road for the Medtronic (NYSE:MDT) Diabetes unit to get its next-generation technology to market. For years, clinical data backed up the MiniMed 780G insulin pump with Guardian 4 sensor technology. Over the last year alone, multiple studies further supported the platform’s impact on glycemic control and diabetes management outcomes. But, the company […]
Medtronic Diabetes unit fully resolves FDA warning letter
Medtronic (NYSE:MDT) announced today that the FDA lifted the warning letter related to its Diabetes business unit headquarters. In December 2021, the FDA issued a warning letter to Medtronic’s Northridge, California, Diabetes headquarters. The letter centered around the inadequacy of specific medical device quality system requirements at the Northridge facility. It scrutinized the areas of […]