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# HeartVista AI-assisted MRI Software Cleared
- URL: https://www.fdaweb.com/heartvista-ai-assisted-mri-software-cleared/
- Published: 2019-10-29T12:00:00.000Z
- Updated: 2026-09-15T01:59:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145370

FDA has cleared a HeartVista 510(k) to use its artificial intelligence-assisted One Click MRI acquisition software for cardiac exams. The clearance is based on data from a recent multi-center, outcome-based study (MR-INFORM), published in the [New England Journal of Medicine](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa1716734&esheet=52119024&newsitemid=20191029005333&lan=en-US&anchor=New+England+Journal+of+Medicine&index=2&md5=ff9639112fc52d1dd7878306b72a9d5d&ref=fdaweb.com), that “demonstrated that non-invasive myocardial perfusion cardiovascular MRI was as good as invasive \[Fractional Flow Reserve\] FFR, the previous gold standard method, to guide treatment for patients with stable chest pain, while leading to 20% fewer catheterizations,” the company says.

The clearance permits HeartVista’s FDA-cleared Cardiac Package to use the software to to acquire standard cardiac views in about 10 seconds with one click while a patient breathes freely. “A unique artifact detection neural network is incorporated in HeartVista’s protocol to identify when the image quality is below the acceptable threshold, prompting the operator to reacquire the questioned images if desired,” the company says.