Tag: FDA clearance
AliveCor Stops Selling KardiaBand, Its ECG Accessory for Apple Watches
AliveCor has ended sales of KardiaBand, its FDA-cleared ECG wristband designed for use with Apple Watches, reports MobiHealthNews.
The company stopped selling the device in...
PhysIQ Receives FDA Clearance for Algorithm Of Patients’ Continuous Ambulatory Respiration Rates
PhysIQ, a company known for applying Artificial Intelligence (AI) in wearable sensor data, received FDA 510(k) clearance for an algorithm facilitating cloud-based analysis of...
BraveHeart Wireless Receives FDA Clearance for its Life Sensor Cardiac Monitoring system
BraveHeart Wireless Inc., a New Hampshire-based leading innovator in clinical-quality biometric wearables, received FDA clearance for its BraveHeart Life Sensor Cardiac Monitoring system.
Related Stretchable...
FDA Clears Wearable Device to Treat Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a complex disorder that causes abdominal pain, cramping, bloating, gas, and diarrhea or constipation, or both. Although it affects...
WatchPAT One, a Fully Disposable Home Sleep Apnea Test Receives FDA Clearance
Sleep apnea is a potentially serious sleep disorder in which breathing repeatedly stops and starts. A study showed that people with severe sleep apnea...
ReStore Exosuit, the First Soft Robotic System for Stroke Therapy Gets FDA Clearance
Stroke is a leading cause of disability, which affects approximately 17 million people worldwide each year, and as many as 80% of people who...