FDA
Nightware Receives FDA Breakthrough Status for its PTSD Nightmare Therapy App
Many people suffering from post-traumatic stress disorder (PTSD) experience nightmares on a regular basis. Nighttime memories often manifest as distressing dreams or nightmares in...
SyncThink’s EYE-SYNC Platform Gets FDA “Breakthrough Device” Designation for Helping Concussion Assessment
The U.S. Food and Drug Administration (FDA) has granted EYE-SYNC, an award-winning VR eye-tracking platform from a leading neurotechnology company SyncThink, Breakthrough Device Designation....
Vapotherm Releases Next Generation Precision Flow Hi-VNI Ventilation System
Vapotherm, a New Hampshire-based med tech company, has released the next generation of its capital unit: The Precision Flow Hi-VNI system. The system is...
Alphabet’s Verily Smartwatch Gets FDA Clearance to Test ECG
Verily, Alphabet’s research organization devoted to the study of life sciences, has received FDA 510(k) clearance for its Study smartwatch. The prescription-only Study Watch,...
Alphabet’s Heart Health Monitoring Smartwatch Gets FDA Clearance
The Verily Study Watch, developed by Verily — an arm of Google parent company Alphabet — has received FDA 510(k) clearance for an “on-demand...
FDA Approves Seizure-Detecting Smartband Embrace 2 for Use by Children
The US Food and Drug Administration (FDA) has approved Embrace 2, a seizure monitoring smart wristband to be used by children ages 6 and...