HIT Consultant November 21, 2025
What You Should Know:
– The U.S. Food and Drug Administration (FDA) has recently issued several key clearances, marking significant advancements across diagnostics, surgery, and remote patient monitoring.
– These FDA clearances reflect a deepening integration of Artificial Intelligence (AI) and advanced technology into clinical workflows, promising greater precision, reduced invasiveness, and expanded access to care.
Diagnostics and Remote Monitoring: AI and Wearables at Scale
A major trend in recent clearances focuses on leveraging AI and comfortable wearables to enhance diagnostic speed and continuity of care.
Wearable Cardiopulmonary Monitoring
Hexoskin Receives 510(k) Clearance for Long-Term ECG and Respiratory Monitoring
Carré Technologies Inc. (dba Hexoskin) received 510(k) clearance for its Hexoskin Medical System (HMS) for continuous long-term ECG, respiratory monitoring, and...
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