IM007
Implicity, Inc.IM007 by Implicity, Inc. is an AI-powered software that analyzes ECG data from Insertable Cardiac Monitors to help healthcare professionals detect various cardiac arrhythmias, such as atrial fibrillation and ventricular tachycardia. It works by processing ECG signals remotely uploaded from compatible devices and provides analysis results to clinicians to support diagnosis and patient monitoring.
Intended Use
IM007 is intended for use by qualified healthcare professionals to assess arrhythmias in Insertable Cardiac Monitor ECG data.
Technology
IM007 is a cloud-based software service with an algorithm based on Machine Learning to analyze ECG signals from ICMs. The software interfaces via API to receive ECG data and sends analysis results back to remote monitoring platforms. There is no client-side application; it is designed to integrate with existing platforms.
Performance
Performance testing was conducted using standard ANSI/AAMI ECG databases and proprietary data, demonstrating that IM007 meets specifications and intended use, showing substantial equivalence to the predicate device without raising safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/24/2021
8 months - 2
FDA Approval
11/3/2021
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