MedAlliance announced today that the first U.S. patient was enrolled in a U.S. clinical trial of its novel sirolimus-eluting balloon. Geneva, Switzerland-based MedAlliance received FDA investigational device exemption (IDE) approval for its Selution SLR drug-eluting balloon in the below-the-knee procedures. One week later, the company enrolled the first patient in its multi-center FDA Selution4BTK trial in […]
FDA clears Insulet Omnipod 5 for children two years and older
Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes. Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older. In June, […]
Acorda Therapeutics COO resigns
Acorda Therapeutics (Nasdaq:ACOR) announced today that Chief Operating Officer Lauren Sabella will resign next month. Pearl River, New York-based Acorda develops therapies designed to restore function and improve the lives of those with neurological disorders. The therapies are delivered via inhalation through the company’s Arcus pulmonary delivery system. Sabella’s resignation will be made effective Sept. […]
Tandem Diabetes Care delivers 1 million insulin boluses using t:connect mobile app
Tandem Diabetes Care (Nasdaq:TNDM) announced today that its users have delivered more than 1 million insulin boluses using its app. Users of the t:connect app feature on their mobile devices have reached the 1 million insulin bolus milestone with the t:slim X2 insulin pump within the first month following its commercial release. San Diego-based Tandem […]
Nuvo, Sheba Medical Center develop AI-powered gestational diabetes management platform
Nuvo Group announced today that it completed the first phase of a collaboration agreement with Sheba Medical Center’s “Sheba BEYOND.” The first phase of the partnership included a pilot program centered around gestational diabetes management. The program shifted necessary non-stress tests (NSTs) to home-based, remote monitoring using Nuvo’s INVU rather than conducting traditional monitoring in […]
Verily’s Onduo, Sword Health collaborate on virtual diabetes care
Onduo announced today that it entered into a strategic collaboration with Sword Health to broaden virtual care for diabetes and other conditions. Sword Health, a digital musculoskeletal (MSK) care provider, will work with Onduo by Verily, an Alphabet sister company of Google. The idea is to offer complementary solutions, broadening access to virtual care benefits […]
Study backs Fluidx embolic device for vessel filling
Fluidx Medical announced today that study results support vessel filling with its GPX embolic device when compared to microspheres. Salt Lake City-based Fluidx designed the GPX embolic device for simple preparation and controllable material delivery, packaged ready-to-use in a syringe and capable of being prepped tableside by a clinician in about 30 seconds. It may […]
Senseonics stock is up as it sticks by revenue guidance
Senseonics (NYSE:SENS) shares were up slightly today on second-quarter results that came up shy of the consensus forecast. The Germantown, Maryland-based continuous glucose monitoring technology developer yesterday evening posted profits of $103.9 million, or 22¢ per share, on sales of $3.7 million for the three months ended June 30, 2022, for a massive bottom-line gain […]
Rapid Dose closes first tranche of $5M financing
Rapid Dose Therapeutics announced today that it closed on the first tranche of a previously announced private placement financing. Burlington, Ontario-based Rapid Dose develops drug delivery products, including the flagship QuickStrip thin, orally dissolvable film that was designed to be infused with a number of active ingredients, including nutraceuticals, pharmaceuticals and vaccines, that are delivered […]
MedAlliance wins second FDA IDE nod for drug-coated balloon
MedAlliance announced today that received conditional FDA investigational device exemption (IDE) for its Selution SLR system. The FDA IDE nod for the novel sirolimus-eluting balloon allows MedAlliance to initiate a pivotal clinical trial for use of Selution SLR in the treatment of occlusive disease of the superficial femoral artery (SFA). Geneva, Switzerland-based MedAlliance’s second IDE […]