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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.
