IoMT/​IoT

To strengthen the safety of medical devices, the FDA has finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. On October 1, the agency issued a final guidance on the content of premarket submissions for the management of...

On August 13, The FDA issued a guidance for industry and FDA staff called “Unique Device Identification System: Small Entity Compliance Guide”. This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA’s September...

Recognizing that the need for effective cybersecurity to ensure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information, the FDA has issued a draft...

Today, the FDA issued its final rule on the unique device identification (UDI) system that, once implemented, will provide a consistent way to identify medical devices. The UDI system should improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more...

The Tacit, a haptic sonar glove that helps a visually impaired person navigate complex environments, has been released as a public prototype. The invention uses ultrasonic sensors to sense objects from about 1 inch to 10 feet away, and translates that information into pressure on the user's wrist.