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FDA clearance

WatchPat One

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

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...
Biofourmis arrhythmia detection RhythmAnalytics

FDA Clears Biofourmis’ AI-Driven Arrhythmia Detection Platform RhythmAnalytics

Biofourmis, a Singapore-based health-tech startup, has received FDA clearance for its cloud-based software, RhythmAnalytics, which helps healthcare professionals in detecting cardiac arrhythmia, or irregular...
Omron Complete Blood Pressure EKG

Omron’s Blood Pressure Monitor with EKG Available for Pre-Order from April 15th

Omron Healthcare has received FDA clearance for its Complete™, blood pressure monitor with EKG capability, and the company said it will start taking pre-orders...
The loop COPD patient monitoring

Spry Health’s the Loop System Wearable Gets FDA Clearance for Monitoring COPD Patients

The US Food and Drug Administration (FDA) has given (501k) clearance to the Loop System, a continuous remote monitor for patients with COPD. Developed...
Senseonics Bridge

Senseonics’ New Program Geared Towards Patients with High-Deductible Insurance Plans

Senseonics, a company well-known for its continuous glucose monitoring (CGM) system announced a new program called Eversense Bridge for patients who carry a high-deductible...