AI Vital Signs Prediction Patch VitalSynth Receives FDA Approval: Warning of Acute Cardiovascular Events 72 Hours in Advance
Israel's Biobeat develops VitalSynth wearable patch that monitors 12 vital signs continuously and uses AI prediction models to warn of acute cardiovascular events up to 72 hours in advance.
Israeli wearable medical device company Biobeat announced on July 18 that its VitalSynth AI vital signs prediction patch received FDA 510(k) clearance. The patch measures only 4cm by 4cm and adheres to the chest to continuously monitor 12 vital signs including heart rate, blood pressure, blood oxygen, respiratory rate, body temperature, and heart rate variability. Its built-in AI model analyzes vital sign time-series patterns and issues warnings an average of 72 hours before acute cardiovascular events.
In clinical trials covering 2,300 high-risk patients, VitalSynth achieved 89 percent sensitivity for early warning of acute myocardial infarction and 92 percent sensitivity for heart failure deterioration. Biobeat CEO Avi Matzliach stated: "A 72-hour window gives physicians enough time to adjust medication regimens or arrange hospital observation, converting emergency events into planned interventions."
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