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 […]
Technology
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. […]
Tandem Diabetes Care CCO is set to resign
Tandem Diabetes Care (Nasdaq:TNDM) filed an SEC Form 8-K announcing its chief commercial officer’s intent to resign. Brian B. Hansen, EVP and CCO, notified the company of his decision to resign on Aug. 17. His resignation goes into effect on Dec. 31, 2023. In connection with Hansen’s resignation, he and the automated insulin delivery technology […]
ICU Medical to close Minnesota facility, cut 81 jobs
ICU Medical (Nasdaq: ICUI) filed with the state of Minnesota to confirm a facility closure and some layoffs. Layoffs continue to impact the medtech industry as companies battle ongoing economic challenges. Over the past year or so, MassDevice has reported on around 18,000 job cuts across the industry. Minnesota’s State Rapid Response Team received a Worker […]
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 […]
Insulet raises 2023 guidance with Omnipod sales up 33%
Insulet (Nasdaq:PODD) stock is down today, even with Street-beating Q2 results and raised guidance. Shares of PODD were down more than 3% at $229.85 apiece by midday trading today. (Insulet announced its earnings yesterday evening.) MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down slightly. The […]
Embecta increases 2023 guidance, reports closed-loop insulin delivery tech progress
Embecta (Nasdaq:EMBC) shares rose this morning as it increased its full-year guidance and shared an update on its automated insulin delivery technology. The company also reported third-quarter results that came in ahead of the consensus forecast. Shares of EMBC ticked up 3.1% at $22.27 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which […]