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 […]
Regulatory/Compliance
FDA clears basal-only insulin pod for type 2 diabetes from Insulet
Insulet (Nasdaq:PODD) announced today that it received FDA clearance for its Omnipod GO long-acting insulin delivery device. Omnipod GO, which received clearance for people with type 2 diabetes aged 18 or older, covers the basal-only insulin population. The target population typically takes daily injections of long-acting insulin. The first-of-its-kind, standalone, wearable insulin delivery system provides […]
FDA approves next-gen MiniMed 780G insulin pump from Medtronic
Medtronic (NYSE:MDT) announced that it received FDA approval for its MiniMed 780G system with the Guardian 4 sensor. The news — posted in the evening on April 21 — has MDT shares up more than 4% to $89.36 apiece in afternoon trading today. (MassDevice’s MedTech 100 Index is up slightly.) The positive news for the […]
Dexcom, Abbott applaud Medicare expansion for CGMs
Dexcom (Nasdaq:DXCM) and Abbott (NYSE:ABT) both commended a change to Medicare policies that benefits continuous glucose monitor (CGM) users. Last month, the Centers for Medicare & Medicaid Services (CMS) published a final local coverage determination (LCD) expanding coverage for CGMs. The ruling has now gone into effect. CMS first published the LCD modifying coverage criteria for […]
FDA clears reader for next-gen Abbott FreeStyle Libre 3
Abbott (NYSE:ABT) announced today that the FDA cleared a reader device for its FreeStyle Libre 3 continuous glucose monitoring (CGM) system. The FDA cleared Abbott’s next-generation FreeStyle Libre 3 in May 2022. Abbott designed FreeStyle Libre 3 as the smallest and thinnest CGM sensor in the world. The system constitutes the size of two stacked […]
Abbott FreeStyle Libre reader warning affects more than 4 million devices
The FDA today issued a notice classifying a recall of Abbott (NYSE:ABT) FreeStyle Libre readers as Class I, the most serious kind. Earlier this week, Abbott initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers. The company said it received a limited number of global reports (0.0017%) from […]
FDA approves over-the-counter Narcan nasal spray
The FDA announced today that it approved Narcan 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter, nonprescription use. Narcan rapidly reverses the effects of opioid overdose and remains the standard treatment for such an overdose. Approval allows direct-to-consumer sales in places like drug stores, convenience stores and more. The FDA nod comes about six […]
Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is not approvable. The FDA said it […]
Analysts receive update on Embecta insulin patch pump progress
BTIG analysts Marie Thibault and Sam Eiber met with Embecta (Nasdaq:EMBC) executives last week and received an update on the company’s current position. Thibault and Eiber met with Embecta CFO Jake Elguicze and Head of Investor Relations Pravesh Khandelwal. Among a series of updates, the BTIG report said Embecta expects a “transitional period” in the […]
Bigfoot Biomedical takes next steps for its holistic diabetes management platform
After executing a significant IP sale, Bigfoot Biomedical looks to double down on its diabetes management platform. Less than two years ago, Bigfoot Biomedical launched its Bigfoot Unity platform in some U.S. states. CEO Jeffrey Brewer last year called it a “transformational attempt” to simplify CGMs and the data they produce. It features a smart […]