The FDA is slated to convene an advisory panel meeting to discuss Angel Medical Systems‘s pre-market approval application for the AngelMed Guardian implantable heart monitor, the agency said today.
The FDA’s Circulatory System Devices Panel is due to meet March 16 to discuss the PMA for the AngelMed Guardian, which is designed to detect the early heart problems that can lead to heart attacks and alert patients to seek medical care.
The proposed indication is for patients with prior acute coronary syndrome events, and at risk for recurrent events, to ST segment changes indicating cardiac ischemia, the federal safety watchdog said.
Angel Medical closed a funding round worth $28 million in December 2012.
The round included existing backers and a new contribution from SOAM Angel Partners, which added principal Dr. Victor Whitman to Angel Medical’s board.