HeartFlow announced the FDA clearance of its new Plaque and RoadMap Analysis AI solutions, making it the “first and only” company to non-invasively assess CAD using anatomy, physiology, and plaque data from coronary CTA exams.
The new Plaque Analysis solution provides data on plaque (calcified, non-calcified, low-attenuation) with similar accuracy as IVUS (the gold standard), helping physicians assess their patients’ cardiovascular risks and adjust care accordingly.
- HeartFlow Plaque Analysis also qualifies for CMS’s new AI-based coronary plaque assessment reimbursement for hospital outpatient settings ($900-$1,000 as of October 1st), allowing HeartFlow to follow a similar coverage-expansion playbook that it established with FFRct Analysis.
RoadMap Analysis “brings stenosis into focus,” giving physicians visual and quantitative insights into the narrowing of all major coronary arteries (RCA, LAD, LCX, and Left Main), including stenosis location and severity.
HeartFlow’s CCTA AI expansion brings it into more direct competition with a growing field of plaque AI vendors (Cleerly, Elucid, Artrya, probably more coming). It also wouldn’t be surprising if some of those plaque AI companies plan to similarly expand into FFRct (Elucid’s FFRct is on the way), suggesting that a shift from CCTA AI point solutions to more comprehensive CAD assessment platforms could be coming.
The Takeaway
HeartFlow has become synonymous with FFRct, but suddenly has a portfolio of cardiac AI solutions (two reimbursable) that significantly expand physicians’ ability to support CCTA CAD assessments. That could be a big deal for HeartFlow, which can leverage its FFRct installed base, playbook, and reputation to bring its AI platform to cardiac imaging teams across the country.
