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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...
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 […]
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 […]
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 […]
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 […]
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 […]