Tag: FDA
FDA Issues Recall for Eversense Continuous Glucose Monitoring System
The US Food and Drug Administration (FDA) has issued a recall for Senseonics’ Eversense Continuous Glucose Monitoring (CGM) system.Read more Senseonics & Glooko Partner...
How Health Wearables Are Improving Patients’ Lives
The proliferation of wearables such as Fitbit to FDA approved medical devices shows that wearable tech is poised to disrupt the healthcare industry.Estimated worldwide...
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,...