Regulatory Affairs Professionals Society

FDA warns device maker, contract testing lab for GMP violations

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...
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Withings' FDA-cleared smart thermometer does more than take your temp - what's new

Withings' BeamO smart thermometer received FDA clearance Thursday. It can take your body temperature and data on heart and lung health. It's available on Withings' website and coming to other ...
MobiHealthNews

FDA clears Kinsa's connected oral thermometer

New York City-based Kinsa Health has received FDA 510(k) clearance for its Kinsa smart thermometer, which raised $52,000 on Indiegogo last Spring. Kinsa's device is not the first smartphone-connected ...
MobiHealthNews

VivaLnk launches Fever Scout, the FDA-cleared thermometer patch

Santa Clara, California-based VivaLnk is officially selling Fever Scout, its FDA-cleared, smartphone-connected wearable thermometer patch for children. The soft, peel-and-stick patch is now available ...
BioWorld

FDA clears Withings Beamo, ‘thermometer of the future’

Withings SA received U.S. FDA clearance for Beamo, its health check-up tool designed to monitor heart and lung function. Described as the ‘thermometer of the future’, Beamo combines the sensors of an ...