Home Tags FDA 501k clearance

Tag: FDA 501k clearance

Strados RESP Gets FDA Clearance

Strados Wins FDA Clearance for its Wireless Lung Sound Measurement Platform

Pennsylvania-based Strados Labs has received the FDA’s 510(k) clearance for its Strados RESP, a platform used to record, measure and assess lung sounds remotely. Read...
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...
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...