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 […]
Food & Drug Administration (FDA)
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 […]
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 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 […]