PulseAI clears an arrhythmia model that reads single-lead ECG from wearables

MedDevice Startups Staff · 21 hrs ago · 2 min read · Via PulseAI release (PR Newswire)

PulseAI said on November 5 that FDA granted 510(k) clearance to its AI arrhythmia analysis model for wearable ECG. The model runs in the cloud and classifies single-lead recordings, including atrial fibrillation and normal sinus rhythm. The Belfast company was founded in 2020 and has not named a wearable partner that will ship it.

The pivotal evidence is a 296-participant prospective study published in Heart Rhythm. Inconclusive interpretations fell about 92 percent against the Apple Watch native algorithm, from roughly 20 percent to under 1 percent. An earlier 91-patient study at Beacon Hospital in Dublin put sensitivity at 93 percent and specificity at 96 percent for atrial fibrillation, against 76 percent and 85 percent for the watch.

Alan Kennedy is founder and chief executive. Justin Mortara, former chief executive of Mortara Instrument, chairs the board, and the seed round was led by Innovation Ulster with the Mortara Group participating. A claim written around the inconclusive rate is cheaper to support than a head-to-head accuracy claim, and it happens to be the number wearable makers complain about.

Questions & Answers

What did PulseAI get FDA clearance for in November 2026?

PulseAI received FDA 510(k) clearance, announced November 5, 2026, for an AI arrhythmia analysis model that interprets single-lead ECG recordings from wearables, classifying rhythms including atrial fibrillation and normal sinus rhythm.

How much did PulseAI's model reduce inconclusive ECG results?

In a 296-participant prospective study published in Heart Rhythm, PulseAI's model cut inconclusive interpretations by about 92 percent, from roughly 20 percent with the Apple Watch native algorithm to under 1 percent.

Where is PulseAI based and who backs it?

PulseAI is based in Belfast, Northern Ireland, and was founded in 2020. Its seed round was led by Innovation Ulster, the investment arm of Ulster University, with the Mortara Group participating.

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