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Diabetes nonprofit organization Tidepool has received FDA clearance for its crowd-sourced Tidepool Loop, the first automated insulin dosing app that works from an Apple Watch.
Light Age received a Form 483 for multiple deficiencies observed in an inspection of its Somerset, N.J., facility including the lack of a device master record and failing to launch corrective and preventive action (CAPA) procedures.
Healthcare analytics company Aetion has entered into a five-year collaboration with the FDA to use its Aetion Evidence Platform (AEP) to analyze novel oncology real-world data and answer questions about cancer prevention, clinical care, diagnostics and treatment.
Cancer care and software technology maker Varian announced that the FDA has granted an investigational device exemption (IDE) for a pivotal multi-center, international trial of its cardiac radioablation (CRA) system for patients with high-risk refractory ventricular tachycardia (VT). Read More
DePuy Synthes — a subsidiary of Johnson & Johnson — has agreed to pay $9.75 million to resolve allegations it violated the False Claims Act by paying kickbacks to a Massachusetts-based orthopedic surgeon to induce his use of DePuy products. Read More
FDA Commissioner Robert Califf laid out his priorities for “a major reformation of our national system for generating medical evidence” and wearable sensors were at the top of his list, in an article in the journal Clinical Trials. Read More
The SEIU-United Healthcare Workers West union in California has petitioned the FDA to issue corrective recalls for Fresenius 2008K2, 2008T, and 2008T BlueStar hemodialysis machines to protect patients from high ultrafiltration rates and assure accurate conductivity — concentration of dialysis fluid.