We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The device makes it “possible to uncover elevated risk for these complications earlier and more accurately than traditional clinical approaches,” the company said.
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.
The commissioner called for improved “access to high-quality data from traditional clinical trials, electronic health records, and personal devices and wearable sensors.”