Home Tags FDA clearance

Tag: FDA clearance

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 the large intestine, IBS often appears […]
To access this page, watch the live stream and videos on-demand, you must purchase the Free Subscription, Premium Subscription or Premium Subscription (6 months, special rate).
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 may be up to three times […]
To access this page, watch the live stream and videos on-demand, you must purchase the Free Subscription, Premium Subscription or Premium Subscription (6 months, special rate).
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 have had a stroke will suffer […]
To access this page, watch the live stream and videos on-demand, you must purchase the Free Subscription, Premium Subscription or Premium Subscription (6 months, special rate).
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 heartbeat. The cloud-based software uses enhanced […]
To access this page, watch the live stream and videos on-demand, you must purchase the Free Subscription, Premium Subscription or Premium Subscription (6 months, special rate).
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 on April 15th in the U.S. […]
To access this page, watch the live stream and videos on-demand, you must purchase the Free Subscription, Premium Subscription or Premium Subscription (6 months, special rate).
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 by Spry Health, a Palo Alto, […]
To access this page, watch the live stream and videos on-demand, you must purchase the Free Subscription, Premium Subscription or Premium Subscription (6 months, special rate).