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 […]
Diabetes
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 […]
Virta Health touts triple-digit growth with insurers as market shifts toward diabetes reversal
Virta Health announced today that it now works with more than 20 national and regional health plans, marking triple-digit growth. San Francisco-based Virta Health, which develops type 2 diabetes reversal technology, has now grown 133% year-over-year with large insurer customers that now offer its treatment to self-funded employer groups, including Humana and Providence Health Plan. […]
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 […]
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 […]
BD chooses ’embecta’ as new name for Diabetes Care spinoff, confirms leadership team
BD (NYSE:BDX) announced today that it named its Diabetes Care business — which it plans to spin off next year — “embecta.” Franklin Lakes, New Jersey-based BD confirmed in May that it plans to spin off its Diabetes Care business as an independent, publicly-traded company during the first half of 2022 and confirmed today that […]
Tandem Diabetes Care expands leadership team
Automated insulin delivery technology developer Tandem Diabetes Care (NSDQ:TNDM) announced new appointments in three executive leadership positions. San Diego-based Tandem named Rick Carpenter as CTO, Libba Sapitsky as SVP of Customer Care and Rizwan Pervez as SVP of Quality and Regulatory. According to a news release, Carpenter, a veteran of more than 30 years in […]
Bigfoot Biomedical touts cloud-based program for managing diabetes
Bigfoot Biomedical officials think their Bigfoot Unity diabetes management program and Bigfoot Clinic Hub could up the game in the space. Milpitas, California-based Bigfoot designed the Bigfoot Unity platform to allow healthcare professionals (HCPs) to review patient data. The information comes from the patient’s prescribed Bigfoot Unity system, integrating with Abbott’s FreeStyle Libre 2 continuous […]
FDA authorizes expansion of Fractyl’s pivotal clinical trial for diabetes reversal tech
Fractyl Health announced today that the FDA gave authorization to expand the Revitalize-1 pivotal clinical study of its Revita DMR system. Lexington, Massachusetts-based Fractyl Health (formerly Fractyl Laboratories) can now increase the sample size of the Revitalize-1 trial (formerly Revita-T2Di trial) from 288 to 420. In September, Fractyl activated the 10th clinical site in the […]
AMF Medical wins breakthrough nod for insulin management system
AMF Medical announced today that it received FDA breakthrough device designation for its Sigi insulin management system. Ecublens, Switzerland-based AMF Medical’s Sigi (for diabetes mellitus treatment) can be programmed to deliver basal and bolus insulin at both set and variable rates. Sigi, an alternate controller-enabled pump, can receive, execute and confirm dosing commands through interactions […]