PulseAI wins FDA 510(k) clearance for AI arrhythmia analysis of wearable ECGs
The Belfast company cites a 296-participant study in Heart Rhythm in which its algorithm improved AFib detection sensitivity and cut inconclusive readings by 92% versus the Apple Watch's native algorithm.
Why it matters
Smartwatch ECGs have spread far faster than clinicians' capacity to read them; IDC counted 164 million smartwatches sold in 2025, and inconclusive tracings force manual review and repeat recordings. PulseAI's clearance lets US providers use a third-party model on wearable recordings rather than relying only on each watchmaker's own algorithm. The supporting evidence is a single prospective study of 296 people, reported by the company. Watch which wearable makers and remote-monitoring services adopt it and whether independent studies match the 92% figure.
Key facts
- FDA 510(k) clearance announced 5 November 2026
- AI arrhythmia analysis model for wearable ECGs
- Prospective study of 296 participants in Heart Rhythm
- 92% fewer inconclusive interpretations than Apple Watch's native algorithm
- IDC: 164 million smartwatches sold worldwide in 2025
- PulseAI is based in Belfast, Northern Ireland