PulseAI gets FDA 510(k) clearance for an AI arrhythmia model that reads wearable ECG recordings
The company says a published 296-participant prospective study showed better AFib detection sensitivity and a 92% reduction in inconclusive readings versus the Apple Watch's native algorithm; the study is cited by the company, not reviewed here.
Why it matters
Smartwatches record hundreds of millions of ECGs, but inconclusive results force clinics to review them by hand. PulseAI's cleared model takes recordings from compatible ECG devices, analyses them in the cloud and returns structured results to the connected app for clinician review. The company, a Belfast spin-out founded in 2020, says it plans to integrate with devices and platforms already in use. Clearance is for the algorithm under the 510(k) pathway; the performance claims come from the company's cited study, so independent replication and real-world workflow data are the next things to watch.
Key facts
- FDA 510(k) clearance announced 2026-11-05
- Prospective study of 296 participants, per the company
- 92% fewer inconclusive interpretations than the Apple Watch native algorithm, per the company
- Recordings analysed in the cloud; structured results returned for clinical review
- Company founded in 2020 in Belfast, Northern Ireland
- Round led by Innovation Ulster Limited with the Mortara Group