The U.S. Food and Drug Administration (FDA) has designated TecTraum Inc’s flagship technology, pro2cool, as a Breakthrough Device, the company announces. The pro2cool System is a novel, non-invasive hypothermic therapy device designed to reduce the severity of...
Varian, a Siemens Healthineers company, announces that the US Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its Embozene microspheres for genicular artery embolization (GAE) for symptomatic knee osteoarthritis. Embozene...
The US Food and Drug Administration (FDA) has granted clearance of the EYE-SYNC technology as an Aid to Concussion, or mild Traumatic Brain Injury (mTBI) Diagnosis, SyncThink — a next gen neurotechnology company and developer of the award-winning EYE-SYNC...
Helius Medical Technologies Inc has received Breakthrough Designation from the US Food and Drug Administration for its PoNS device as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke, it announces. The device is designed for use...
The MIScoli system, a vertebral body tethering (VBT) device to treat scoliosis in young adolescents, has received Breakthrough Device Designation from the U.S. Food and Drug Administration, Spino Modulation Inc, a subsidiary of Montreal-based Spinologics, announces....
