Twiist Automated Insulin Delivery System Cleared by the FDA
DEKA Research and Development Corp has received 510(k) clearance FDA for the twiist Automated Insulin Delivery system powered by Tidepool.
DEKA Research and Development Corp has received 510(k) clearance FDA for the twiist Automated Insulin Delivery system powered by Tidepool.
Sibel Health’s continuous wearable monitoring solution, ANNE One, received FDA clearance for use with adolescents 12 and older.
The FDA announced that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices.
Siemens Healthineers has received U.S. FDA clearance for the Biograph Vision.X PET/CT scanner, featuring advanced detector technology with small LSO crystals and fast time-of-flight capabilities.
Senators Durbin and Blumenthal have requested the Government Accountability Office (GAO) to review the FDA's policies on medical device recalls, citing the Philips Respironics case and a significant increase in recalls.
Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.
The FDA is establishing a Digital Health Advisory Committee in 2024, comprising experts from various fields, to advise on the safe and effective regulation of digital health technologies like AI, virtual reality, and wearables, aiming to promote innovation while safeguarding public health.