Devices

Heartvue’s MRI-Reviewing Software Cleared

FDA has granted Heartvue.ai a 510(k) clearance (K260811) for its Heartvue.Proton, a machine learning–powered software for viewing, post-processing, and quantitative evaluation of cardiovascular magnetic resonance images (MRI). Cardiac MRI is the gold standard for assessing cardiac structure and function, but manual analysis can take up to an hour or more, limiting patient access to quantitative cardiac care.

“Heartvue.Proton automates time-consuming measurements across three domains — 2D linear dimensions, ventricular volumes and ejection fraction, and blood flow quantification — while keeping every result under the review and control of a qualified physician,” the company says. “The platform integrates directly with hospital PACS and EHR systems and fits into existing cardiology and radiology reading workflows.”

The company also notes that the clearance includes an FDA-authorized Predetermined Change Control Plan that allows it to “pre-clear” certain changes without having to go back to the agency with another 510(k). “For Heartvue, this means its machine learning models can improve within pre-specified bounds without requiring a new submission for each update — an important capability for keeping AI performance current as clinical data grows,” it says.

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