PulseAI says its wearable ECG analysis model received FDA clearance
Founder Alan Kennedy's Belfast-based PulseAI announced U.S. regulatory clearance on November 5th. A 296-person study reported 92% fewer inconclusive Apple Watch ECGs using its algorithm.
By Ryan Merket · Published
Primary source: PR Newswire Business Technology
Why it matters
Wearable ECGs only help clinics if the readings are clear enough to act on. PulseAI's clearance gives device makers and providers a regulated AI layer aimed at cutting inconclusive results, manual review and repeat recordings as patient-generated heart data keeps growing.
PulseAI founder and CEO Dr Alan Kennedy has spent years working on a stubborn problem in wearable cardiology: watches can record an ECG far more easily than clinics can interpret one. PulseAI said on November 5th that its wearable ECG analysis model had received FDA clearance; the announcement did not establish the decision date or specific compatible devices.…
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