Zacks Equity Research today reported that Medtronic (NYSE:MDT) stands to gain from yesterday’s CMS coverage expansion for diabetes technology. CMS’s expanded coverage, confirmed by Medtronic yesterday, covers all types of CGMs (continuous glucose monitors), including adjunctive and non-adjunctive CGMs. The coverage includes CGMs that integrate with Medtronic insulin pumps. Zacks said the new rule will likely […]
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CMS expands Medicare coverage to CGMs that integrate with Medtronic insulin pumps
Medtronic (NYSE:MDT) announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) will expand coverage for CGMs. CMS’ expanded coverage covers all types of CGMs (continuous glucose monitors), including adjunctive and non-adjunctive CGMs, and it notably covers CGMs that integrate with Medtronic insulin pumps. According to a news release, the proposed rule was […]
Government warns on cybersecurity issue with Fresenius Kabi’s Agilia Connect infusion system
The U.S. Cyber Security & Infrastructure Security Agency today issued a medical advisory for the Fresenius Kabi Agilia Connect infusion system. Fresenius Kabi’s Agilia Connect infusion system has been deemed “exploitable remotely/low attack complexity” by the agency. Successful exploitation of vulnerabilities could allow an attacker to gain access to sensitive information, modify settings or parameters […]
Bigfoot Biomedical announces trio of new senior hires
Bigfoot Biomedical announced today that it appointed three senior hires with experience in the diabetes and healthcare sectors. Milpitas, California–based Bigfoot hired Matthew Clemente as SVP of development, Robin A. Beadle as VP of marketing and Scott Snead as VP of national accounts. All three positions are newly created. Bigfoot said in a news release […]
Alfred E. Mann Foundation brings former Alcon, Siemens Healthineers execs into C-suite
The Alfred E. Mann Foundation for Scientific Research (AMF) today confirmed the appointment of two new senior executives. Los Angeles-based AMF appointed Charles Nelson as its new COO and Corey Dishmon as its chief legal officer/chief business officer. Nelson joins AMF from Alcon, where he oversaw the manufacturing science and technology organization. He is a […]
Medtronic Diabetes receives FDA warning over quality system requirement inadequacies
Medtronic (NYSE:MDT) announced today that it received an FDA warning letter after an inspection of its Diabetes Business. The company received the letter on Dec. 9 for its Northridge, California facility — the Medtronic Diabetes Business headquarters — following an inspection that concluded in July 2021. FDA’s warning letter to Medtronic focused on the inadequacy […]
Former pediatric endocrinologist joins Medtronic’s diabetes business as medical affairs director
Medtronic (NYSE:MDT) announced this week that former pediatric endocrinologist Dr. Jennifer McVean has joined its diabetes business. McVean, a former pediatric endocrinologist for the University of Minnesota Physicians and an associate professor in the pediatrics department at the University of Minnesota Medical School, will take up a role aimed at augmenting Medtronic’s commitment to providing […]
Baxter touts data supporting use of machine learning for infusion pump programming
Baxter (NYSE:BAX) announced today that data shows the potential for machine learning supporting decision-making with infusion pump programming. Deerfield, Illinois-based Baxter presented the data from a retrospective study — part of a collaboration with MedAware aimed to develop next-generation dose error reduction software — at the American Society of Health-System Pharmacists (ASHP) 2021 Midyear Clinical […]
Ocular Therapeutix touts positive trial results of ophthalmic insert for dry eye disease
Ocular Therapeutix (NSDQ:OCUL) announced today that it reported positive results from a Phase 2 trial of its dry eye disease treatment. Bedford, Massachusetts-based Ocular Therapeutix’s U.S.-based Phase 2 clinical trial evaluated OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of dry eye disease. The randomized, double-masked, vehicle-controlled, multi-center trial evaluated two different formulations of […]
Report: Insulet expects delays in FDA review for Omnipod 5 with launch pushed back
The highly anticipated launch of the Insulet (NSDQ:PODD) Omnipod 5 may not come as soon as thought as an FDA review drags on. SeekingAlpha reported that Insulet CEO Shacey Petrovic, speaking at the Nasdaq Investor Conference, said the regulatory agency will likely not complete its review of the next-generation Omnipod 5 before the end of […]