FDA Proposes Ban on Electrical Stimulation Devices
The FDA proposed a ban on electrical stimulation devices (ESDs) designed to mitigate self-injurious or aggressive behavior.
The FDA proposed a ban on electrical stimulation devices (ESDs) designed to mitigate self-injurious or aggressive behavior.
QT Medical announced that it has received 510(k) clearance from the FDA for PCA 500 use in an acute care setting.
DermaSensor received FDA clearance for its AI-powered, real-time, non-invasive skin cancer evaluation system.
EndoQuest Robotics' Flexible Robotic System has been accepted into the U.S. FDA's Safer Technologies Program (STeP), allowing for a streamlined development process aimed at enhancing medical treatment safety. The company plans to collaborate further to advance its endoluminal robotic system for minimally invasive surgery.
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.