Devices

Breakthrough Status for AI Electrocardiogram

FDA has granted Powerful Medical a breakthrough device designation for its PMcardio STEMI artificial intelligence (AI) electrocardiogram model for detecting ST-elevation myocardial infarction (STEMI) and STEMI equivalents — described by the company as a life-threatening cardiac condition requiring immediate intervention.

The electrocardiogram (ECG) remains the primary tool for rapid heart attack diagnostics, but often this standard of care fails to detect them accurately and timely, resulting in critical delays in treatment, according to the company. “PMcardio is the only solution 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) and bridging a vital gap in early, precise heart attack diagnosis,” it says.

The AI model was developed using almost 19,000 ECGs with suspected acute coronary syndromes (ACS) from an international database with clinically validated outcomes, according to the company. The model was evaluated in an international cohort and compared with STEMI criteria and ECG experts in detecting OMI, it says. The primary outcome of OMI was an acutely occluded or flow-limiting culprit artery requiring emergent revascularization. The company says the AI model “demonstrates superior accuracy to detect acute OMI when compared with STEMI criteria. This suggests its potential to improve ACS triage, ensuring appropriate and timely referral for immediate revascularization.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome