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Fierce Biotech1d

Cardiosense scores FDA clearance for wearable sensor that monitors heart function

Medical AI company Cardiosense has claimed FDA clearance for its CardioTag device, a wearable sensor that provides a ...

FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
MPR1d

CardioTag, a Wearable Cardiac Monitoring Device, Gets FDA Clearance

The wearable, noninvasive CardioTag is designed to capture electrocardiogram, photoplethysmogram, and seismocardiogram signals, as well as heart rate and pulse rate.
TMCnet1d

Cardiosense Receives FDA 510(k) Clearance for the CardioTag™ Device, Paving the Way for Advanced Cardiac Function Monitoring

Cardiosense, a medical AI company transforming cardiovascular disease management, today announced that the U.S. Food and Drug ...
Becker's Hospital Review7y

FDA greenlights AI algorithm to detect wrist fractures

The FDA approved an artificial intelligence algorithm designed to help physicians detect wrist fractures May 24. The computer-aided detection and diagnosis software, dubbed OsteoDetect and ...
Becker's ASC9h

FDA clears Cardiosense for wearable cardiac monitor

Chicago-based Cardiosense has received 510(k) clearance from the FDA for its CardioTag device, a multimodal wearable sensor.  The CardioTag is designed to provide clinicians with a comprehensive, ...
Que.com on MSN6d

AI in FDA Drug Approvals Sparks Controversy Over Fabricated Studies

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...
MobiHealthNews6y

Study results support FDA approval of diagnostic algorithm, but experts ...

“The study results demonstrate the safety of autonomous AI systems to bring specialty-level diagnostics to a primary care setting, with the potential to increase access and lower cost.” While these ...