Tag: FDA clearance
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 […]
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 […]
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 […]
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 […]
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. […]
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, […]