FDA Clears Belfast AI That Cuts Smartwatch ECG Inconclusives From 20% to Near-Zero
AI-generated summary PulseAI announced that the FDA cleared its artificial intelligence model under the 510(k) pathway to interpret wearable single-lead electrocardiograms. PulseAI says its algorithm reduced inconclusive interpretations from roughly 20 percent to under one percent in a clinical study involving 296 participants.