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. […]
Patient Monitoring
Nemaura Medical wins regulatory approval for non-invasive glucose sensor in the Middle East
Nemaura Medical (Nasdaq:NMRD) announced today that it received Saudi Food and Drug Authority (SFDA) approval for its sugarBEAT sensor. The company develops daily, non-invasive, disposable, wearable glucose sensors. It also offers digital diabetes management tools and earlier this year added CGM-guided insulin dose titration to its offerings. Nemaura’s sugarBEAT, a CE-marked device, offers non-invasive, flexible continuous […]
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) […]
Nemaura Medical secures $6.5M in funding
Nemaura Medical (Nasdaq:NMRD) announced that it brought in $6.5 million in non-dilutive funding through a clean debt facility. The Loughborough, England-based company said its debt facility features no warrants or convertible elements. It comes from the company’s existing lender. Nemaura Medical did not list an intended use for the added funds. The company develops daily, […]
Senseonics posts mixed Q2, submits to FDA for iCGM designation
Senseonics (NYSE:SENS) shares took a hit today on second-quarter results that missed the consensus sales forecast. Shares of SENS fell nearly 12% at 65¢ apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — stayed relatively even. The Germantown, Maryland–based implantable continuous glucose monitor […]
Tandem provides pathway to transition to new insulin pump platform
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it made a new, limited-time offer for its Tandem Choice technology access program. San Diego-based Tandem Diabetes Care’s program provides new and renewing, eligible users of its insulin pump a pathway to its new offerings. Users of the t:slim X2 insulin pump in the U.S. can use the […]
Tandem resets 2023 guidance due to reduced sales visibility from new product disruption
Tandem Diabetes Care (Nasdaq:TNDM) shares took a hit on second-quarter results that included amended full-year financial guidance. Changes to the automated insulin delivery technology maker’s outlook reflect updates to its portfolio and reduced visibility on sales for the near future. Shares of TNDM fell 15% to $27.19 apiece after the market closed today. MassDevice’s MedTech 100 […]
Glytec unveils updated Glucommander insulin dosing software
Glytec today unveiled the newest version of its Glucommander insulin dosing software that enables best practice, personalized care. The Glucommander platform helps to streamline workflows, improve outcomes and support electronic health record (EHR) systems. Waltham, Massachusetts-based Glytec says it closely follows the next evolution of GlucoMetrics released this past spring. GlucoMetrics provides new insights and […]
Abbott FreeStyle Libre 3 reader is now available, covered by Medicare
Abbott (NYSE:ABT) has made its FreeStyle Libre 3 reader available in the U.S., enabling people on Medicare to access the system. The FreeStyle Libre 3 reader pairs with the company’s latest continuous glucose monitor (CGM) sensor, cleared by the FDA last year. The addressable market for the sensor keeps growing, with massive coverage expansions all […]
Dexcom more than doubles profits on 25% sales growth in Q2
Dexcom (Nasdaq:DXCM) shares are up today on second-quarter results that topped the consensus forecast. Shares of DXCM rose 2.3% at $132.35 apiece after the market closed yesterday. By the next afternoon, DXCM shares were up more than 4% to $134.71 apiece. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device […]