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FDA eXciteOSA sleep apnea

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 and snoring – and it doesn’t […]
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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 more Kaia Health Partners With […]
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Biotronik FDA clearance for BIOMONITOR IIIm ICM

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 (ICM). Read more BIOTRONIK Receives FDA […]
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Apple watch FDA clearance AFib

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 comes just over two years after […]
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Nanowear SimpleSENSE FDA Clearance

Nanowear’s Cloth-Based Wearable Remote Monitoring Platform SimpleSENSE Cleared By FDA

Nanowear, a leading connected-care and remote diagnostic platform, announced it has received FDA Class II 510(k) clearance for a first-of-its-kind cloth-based diagnostic platform, SimpleSENSE. SimpleSENSE is a multi-parameter remote diagnostic […]
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Vitls Wins FDA Clearance

Vitls Wins FDA Clearance For Its Remote Patient Monitoring Platform

Houston, Texas-based Vitls Inc. won FDA 510(k) clearance for its Vitls Platform. The Vitls Platform is a combination of a vitals monitoring patch, cloud storage, and an app that lets […]
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