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FDA clearance

Dexcom G6 Pro

Dexcom Receives FDA Clearance for Dexcom G6 Pro Continuous Glucose Monitor

Dexcom, a maker of continuous glucose monitoring systems for diabetes management, received FDA clearance of its Dexcom G6 Pro Continuous Glucose Monitoring (CGM) System...
Biobeat blood pressure monitor

Biobeat’s Wearable Blood Pressure Monitors Receive FDA 501K Clearance

Biobeat, an Israeli bio-medical technology company received FDA 501K clearance for its patch and smartwatch for measurement of blood pressure, oxygenation and heart rate...
AliveCor KardiaBand

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 fda clearance

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 Life Sensor

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 IBS device

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...