Implicity Gets FDA’s 510(k) Clearance for Its ECG Analyzer

Implicity has received the FDA’s 510(k) clearance for a medical algorithm that analyzes ECG data from implantable loop recorders (ILRs).

The ILR ECG Analyzer applies artificial intelligence-based software to heart rhythm data collected by certain Medtronic ILR models.

The analyzer can now be used in combination with implantable loop recorders to “improve arrhythmia detection and help electrophysiologists and their teams avoid wasting time reviewing nonactionable events,” Implicity said.