Tag
4 articles
The FDA has selected Dexcom as the first company to offer an unapproved device to Medicare patients under its new TEMPO pilot program, using enforcement discretion to accelerate access to digital health innovations.
French medtech Tissium has raised €60M to introduce its sutureless nerve repair system to U.S. operating rooms, offering a potentially less invasive alternative to traditional nerve suturing.
The FDA is launching a pilot program to monitor clinical trials in real time using AI and cloud computing, aiming to speed up drug approvals.
California-based startup Kintsugi is shutting down after failing to secure FDA clearance for its depression-detecting AI, releasing most of its technology as open-source. The company's experience highlights the regulatory challenges facing mental health AI startups.
