The FDA today warned that the recall of an infusion pump from Intera Oncology is Class I, the most serious kind. Intera recalled the Intera 3000 hepatic artery infusion pump after receiving reports from clinicians that the pumps were delivering medications (flow rate) faster than expected. If the pump delivers infusions at faster than expected flow […]
Study shows workplace productivity improvements with One Drop type 2 diabetes tech
One Drop today announced positive results from a trial of its digital health platform for people with type 2 diabetes. Employees using the One Drop digital diabetes management platform experienced significant productivity and functioning gains and were less likely to experience presenteeism at follow-up compared to control groups. One Drop’s platform uses AI to provide […]
PhysIQ, InCarda Therapeutics to collaborate on AFib treatment tech
PhysIQ announced today that it entered into a strategic collaboration with InCarda Therapeutics. Newark, California-based InCarda Therapeutics develops first-of-their-kind inhaled therapies for treating cardiovascular diseases. Get the full story at our sister site, MassDevice.
BD wins patent fight against Baxter over drug-transfer system
BD (NYSE:BD) picked up a legal victory in a patent spat with Baxter (NYSE:BAX) over a system for moving drugs. A federal judge in Chicago ruled that BD’s PhaSeal system for transporting hazardous drugs between syringes and vials doesn’t infringe two patents belonging to Baxter. U.S. District Judge Joan Lefkow granted BD summary judgment on […]
Glytec, CPS collaborate on glycemic management support for pharmacy departments
Glytec announced today that CPS Solutions selected it to serve as an insulin management technology resource. Waltham, Massachusetts-based Glytec will serve as a resource for CPS’ more than 2,200 pharmacy professionals across more than 800 healthcare facilities nationwide. Through the collaboration, CPS client facilities can contract for Glytec’s eGlycemic Management System (eGMS) and Glytec’s technical […]
Hygieia appoints diabetes veteran Doug Lawrence as CEO
Hygieia — a developer of digital therapeutics for insulin therapy — announced today that it appointed Doug Lawrence as its CEO. Lawrence will take the corner office at Livonia, Michigan-based Hygieia with responsibilities for leading operations, development, and global growth of the company and its d-Nav insulin management program. The FDA-cleared d-Nav system autonomously adjusts […]
First U.S. patient enrolled in MedAlliance Selution SLR drug-eluting balloon trial
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 […]
