Powerful Medical has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its PMcardio ST-segment elevation myocardial infarction (STEMI) artificial intelligence (AI) electrocardiogram (ECG) model.
PMcardio is capable of detecting both STEMI and STEMI equivalents on the ECG—aligning with the emerging emphasis on a paradigm shift towards occlusion myocardial infarction (OMI) diagnosis and bridging a vital gap in early, precise heart attack diagnosis, Powerful Medical states in a press release.
“For the last 20 years, life-saving treatment exists for heart attack patients, yet far too many still don’t receive the urgent care they need due to delays in diagnosis and inefficient triage,” says Robert Herman, chief medical officer of Powerful Medical. The company’s press release adds that this is especially critical in settings where immediate specialist evaluation isn’t available—only 17% of patients presenting to rural centres make it to the cath lab in time for intervention.
“By equipping physicians and allied providers with an AI-powered tool for accurate and immediate STEMI detection, available around the clock, we can bridge this gap, ensure timely treatment, and improve patient outcomes, often preventing avoidable deaths,” adds Herman.
The FDA’s breakthrough device designation provides PMcardio with an expedited review process and collaboration with the agency on its path toward market authorisation. This designation is reserved for technologies that offer significant advantages over existing solutions and address unmet medical needs.
“FDA breakthrough device designation is a pivotal milestone in our effort to revolutionise heart attack detection and ensure every patient receives immediate, life-saving care,” says Felix Bauer, COO of Powerful Medical.
“We’re committed to bringing this life-saving technology to the USA, the largest healthcare market in the world. This recognition by the FDA validates the impact of our innovation and brings us closer to transforming emergency cardiac care on a global scale,” adds Martin Herman, CEO.
