Tag: FDA clearance
Nuvo Group’s Remote Uterine Activity Monitoring Module Gets 510(k) FDA Clearance
Remote pregnancy monitoring company Nuvo Group announced that it has received FDA clearance to add a new uterine activity module that provides capability for...
Masimo Receives FDA 510(k) Clearance for Prescription and OTC Use of Radius Tº Thermometer
Masimo has secured 510(k) clearance from the FDA for the prescription and over-the-counter (OTC) use of its Radius Tº wearable and wireless thermometer for...
FDA Authorizes Daytime Device to Reduce Snoring and Mild Obstructive Sleep Apnea
The U.S. Food and Drug Administration (FDA) has authorized marketing of eXciteOSA – a neuromuscular tongue stimulating device that could help prevent sleep apnea...
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.
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BIOTRONIK Wins FDA Clearance for its Vital Data Sensor in BIOMONITOR IIIm ICM
German biomedical company BIOTRONIK has won FDA clearance for the Vital Data Sensor, a body temperature component within the BIOMONITOR IIIm injectable cardiac monitor...
Apple Gets FDA Clearance for its Updated Version of ECG to Detect AFib
An updated version of Apple’s ECG feature received FDA clearance, allowing it to add abnormal heart rhythm known as Atrial Fibrillation (AFib). The news...