ARS Pharmaceuticals (Nasdaq:SRPY) says the FDA issued a complete response letter (CRL) regarding its neffy epinephrine nasal spray. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company initially set an anticipated target action date of mid-2023 for its PDUFA […]
Food & Drug Administration (FDA)
Admetsys wins FDA breakthrough nod for automated glucose control tech
Admetsys announced today that it received FDA breakthrough device designation for its automated glucose control system. The system — also a continuous blood diagnostics system — aims to fill a key gap in the standard of care. Boston-based Admetsys designed it to automatically measure multiple blood analytes, including glucose, in real time. It requires no […]
GLP-1 startup i2o looks to revive diabetes drug-eluting implant from Intarcia
i2o Therapeutics says it acquired the diabetes-treating assets of one-time medtech unicorn Intarcia Therapeutics. The Boston-based company acquired and integrated Intarcia’s proprietary assets and made a big personnel move. With CEO Ravi Srinivasan moving onto other opportunities, i2o named Kurt Graves as chair, president and CEO. Graves previously served as executive chair of the i2o […]
FDA clears new infusion pump and software from ICU Medical
ICU Medical (Nasdaq:ICUI) announced today that the FDA granted 510(k) clearance to its Plum Duo infusion pump with LifeShield infusion safety software. The San Clemente, California-based company plans to make the pump and software available to U.S. customers in early 2024. Plum Duo, the latest addition to the ICU Medical infusion device portfolio, builds on […]
Welldoc gets FDA nod for CGM-guided insulin bolus dosing software
Welldoc announced today that it won the 11th FDA 510(k) clearance for its BlueStar digital diabetes management platform. The clearance comes just a week after BlueStar received its 10th FDA clearance for using connected insulin dosing data in personalized bolus insulin dosing recommendations. Welldoc’s newest clearance enables BlueStar to provide bolus insulin dose recommendations based […]
Medtronic pleased with Diabetes progress as new CGM’s FDA review ‘is progressing’
After ending fiscal 2023 on a high, the Diabetes unit at Medtronic (NYSE:MDT) continues to roll on into the company’s new fiscal year. To finish fiscal 2023 (in April), Medtronic received FDA approval for its next-generation MiniMed 780G automated insulin delivery system. Shortly after, the company fully resolved a warning letter issue with the FDA. […]
BioCorRx submits implantable opioid use disorder treatment to FDA for expanded access
BioCorRx announced today that it submitted to the FDA an expanded access program application for its BICX104 implantable naltrexone pellet. BICX104, a biodegradable implantable pellet, treats opioid use disorder (OUD). The expanded access program would enable the treatment to reach eligible patients before full FDA approval. The FDA program provides access to products before approval […]
FDA clears Welldoc BlueStar for personalized bolus insulin dosing recommendations
Welldoc announced today that it received the 10th FDA 510(k) clearance for its BlueStar diabetes digital health solution. The latest regulatory nod enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations. Columbia, Maryland-based Welldoc aims to make this enhanced functionality available commercially in 2024. “The receipt of our 10th 510(k) […]
FDA approves another over-the-counter Naloxone nasal spray
Harm Reduction Therapeutics announced that it received FDA approval for its over-the-counter RiVive naloxone nasal spray. Pittsburgh-based HRT designed the 3 mg naloxone HCl nasal spray for the emergency treatment of opioid overdose. Approval helps make free or low-cost OTC nasal spray widely available in the U.S. The FDA first approved Narcan 4 mg OTC […]
Baxter warns on some infusion pumps due to potential false alarms
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 […]
