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Sean Whooley

Tandem Diabetes Care wins CE mark for Mobi insulin pump with Control-IQ+ technology

May 20, 2025 By Sean Whooley

Tandem Diabetes Mobi insulin patch pump worn on hiker's leg drug delivery

Tandem Diabetes Care (Nasdaq:TNDM) filed an SEC Form 8-K to state that it received CE mark for its Mobi insulin delivery system. San Diego-based Tandem can now market the miniature, durable automated insulin delivery system with Control-IQ+ technology in Europe. According to the filing, the company intends to pursue additional regulatory and pre-commercial activities now. […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Regulatory/Compliance, Technology Tagged With: Tandem Diabetes Care

Glooko adds chief strategy officer to chief medical officer’s title

May 19, 2025 By Sean Whooley

Glooko Logo

Glooko announced today that it expanded the position of Dr. Mark Clements to make him its chief medical and strategy officer. Clements became the Palo Alto, California-based diabetes management company’s fractional chief medical officer in 2016. He now steps into an expanded, full-time role designed to integrate Glooko’s clinical vision, product roadmap and data solutions. […]

Filed Under: Business/Financial News, Diabetes, Personnel, Technology Tagged With: glooko, Personnel Moves

Cordis launches 10,000-patient registry for drug-eluting balloon

May 19, 2025 By Sean Whooley

Cordis today announced the initiation of a global registry to track real-world outcomes for the Selution SLR drug-eluting balloon (DEB). Miami Lakes, Florida-based Cordis expects the SELUTION Global Coronary Registry to enroll up to 10,000 patients worldwide. It says that would make it one of the largest coronary DEB registries to date. Investigators plan to […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Vascular Tagged With: cordis

Senseonics opens $50M public offering, $25M private placement with Abbott

May 15, 2025 By Sean Whooley

Senseonics logo

Senseonics (NYSE:SENS) announced today that it commenced an underwritten public offering of common stock worth $50 million. The long-term implantable continuous glucose monitor (CGM) maker expects to grant underwriters a 30-day option to purchase up to an additional 15% of the total number of shares of stock offered in the public offering. All shares to be […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Funding Roundup, Implants, Patient Monitoring, Technology Tagged With: Senseonics

Study links Abbott CGM use to lower risk of hospitalizations due to heart complications

May 15, 2025 By Sean Whooley

Abbott FreeStyle Libre linked with fewer hospitalizations from heart complications in people with diabetes (1)

Abbott (NYSE:ABT) today announced results from real-world studies demonstrating benefits with its FreeStyle Libre continuous glucose monitoring (CGM) technology. Results from the REFLECT studies show that Libre CGM is associated with a significant reduction in the risk of hospitalization for heart complications in people with diabetes. Data demonstrated that CGM can help lessen the severity […]

Filed Under: Cardiovascular, Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: abbott

Go-Pen ApS wins FDA nod for user-filled insulin pen

May 14, 2025 By Sean Whooley

Go-Pen ApS Go-Pen insulin pen (1)

Go-Pen ApS announced recently that it received FDA 510(k) clearance for its Go-Pen cost-effective, user-filled insulin pen. Copenhagen, Denmark-based Go-Pen ApS says that, despite advances in diabetes technology, approximately one-third of insulin users worldwide (more than 20 million people) rely on traditional vials and syringes due to cost and access limitations. According to a news […]

Filed Under: Diabetes, Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Go-Pen

BD files patent infringement lawsuit against Baxter over infusion pump tech

May 13, 2025 By Sean Whooley

Baxter Novum IQ Infusion (BD alleges patent infringement against the system)

BD (NYSE:BDX) filed a lawsuit in a U.S. District Court alleging patent infringement by Baxter (NYSE:BAX) related to infusion pump technology. The company filed its complaint in the U.S. District Court for the District of Delaware on May 12, 2025. BD’s complaint singles out six specific patents: the “180,” “058,” “880,” “868,” “414,” and “703” […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Legal News, Technology Tagged With: Baxter, BD

Tandem Diabetes Care subsidiary earns new FDA clearance for insulin infusion set

May 13, 2025 By Sean Whooley

Tandem Diabetes Care updated logo

Tandem Diabetes Care (Nasdaq:TNDM) shared in an SEC filing that its Capillary Biomedical (CapBio) subsidiary won FDA 510(k) clearance for a new infusion set. The company won clearance for its SteadiSet Infusion Set, according to an SEC Form 8-K. It’s a wearable infusion set that delivers insulin from an insulin pump to the body. San Diego-based […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Technology Tagged With: capillarybiomedical, FDA, Tandem Diabetes Care

Glucotrack can proceed with long-term glucose monitor study in Australia

May 13, 2025 By Sean Whooley

GlucoTrack updated Logo (1)

Glucotrack (Nasdaq:GCTK) announced today that it received a hospital’s ethical approval to study its continuous blood glucose monitor (CBGM). The St. Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) gave the nod for a long-term clinical study. It plans to include participants with both type 1 and type 2 diabetes using the CBGM. Rutherford, New […]

Filed Under: Business/Financial News, Clinical Trials, Diabetes, Drug-Device Combinations, Implants, Patient Monitoring, Technology Tagged With: Glucotrack

Dexcom promotes Jake Leach to president role

May 13, 2025 By Sean Whooley

Jake Leach Dexcom COO

Dexcom (Nasdaq:DXCM) announced today that it promoted Jake Leach to the role of president, in addition to his post as COO. Leach originally took over as COO in 2022. He previously served as chief technology officer (CTO), starting in 2018. In that role, he led the company’s research, product development, product management and engineering departments. […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Personnel, Technology Tagged With: Dexcom, Personnel Moves

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