FDANews
FDAnews Device Daily Bulletin

FDA Panel Discusses AngelMed Guardian

March 16, 2016

An FDA panel is meeting today to discuss and vote on information related to the premarket approval application for the AngelMed Guardian System.

Sponsored by Angel Medical Systems, the system is an implantable cardiac monitor intended to alert patients to ST segment shifts indicating coronary ischemia.

According to FDA briefing documents, a clinical study demonstrated that the AngelMed Guardian met its primary safety endpoint, but not the primary effectiveness endpoint.  — Anisa Jibrell