DermaSensor received FDA clearance for its AI-powered, real-time, non-invasive skin cancer evaluation system.
Tag: FDA Breakthrough Device Designation
Sensome has been granted a Breakthrough Device designation by the FDA for its Clotild Smart Guidewire System designed to improve the treatment of ischemic stroke patients.Read More
NIVA|HF is an investigational device designed to monitor the venous waveform in heart failure patients using VoluMetrix’s Non-Invasive Venous waveform Analysis (NIVA) technology.Read More
Intelligent Implants SmartFuse technology is a wirelessly enabled orthopedics platform that has been designed to remotely stimulate, control, and monitor bone growth.Read More
The U.S. FDA has granted cryoablation technology developer IceCure Medical Ltd. Designation as a Breakthrough Device for its lead product, ProSense, and proposed indication for use, including for use in the treatment of patients with T1 invasive breast cancer.Read More