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Fierce Biotech2d
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 ...
MPR2d
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.
Pharmabiz9h
Cardiosense receives US FDA 510(k) clearance for its CardioTag device
Cardiosense receives US FDA 510(k) clearance for its CardioTag device: Chicago Friday, August 1, 2025, 17:00 Hrs [IST] Cardiosense, a medical AI company transforming cardiovascula ...
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 ...
TMCnet2d
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 ...
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 ...
Becker's ASC1d
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 MSN7d
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 ...