Category: FDA Updates

Clearances

Latest

STeP Program Accepts EndoQuest Flexible Robotic 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.

Draft Guidances

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FDA Establishes Digital Health Advisory Committee

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.