InfoBionic announced it received FDA 510(k) clearance for its next-generation remote ECG monitoring device with a Bluetooth diagnostic six-lead sensor for patients who require cardiac monitoring.
In a previous prospective, nonrandomized trial, researchers evaluated data from 1,003 adults from multiple sites with risk factors for stroke and no known AF and wore a continuous ambulatory heart rhythm monitor (MoMe) for up to 30 days.
As Healio previously reported, the AI algorithm, when applied to existing ECGs in adults at high risk for stroke, identified signs of AF risk during normal sinus