Morningstar

FDA Clears Heartflow Coronary Plaque Technology

Provided by Dow Jones Sep 22, 2025, 8:41:00 PM

By Nicholas G. Miller

The Food and Drug Administration cleared Heartflow's technology to quantify coronary plaque and the platform is now available, the company said.

The technology, which uses AI and data from 273,000 patients, offers medical providers a visual representation of plaque types, allowing for rapid assessment of coronary artery disease location and severity.

Heartflow also said insurance provider Cigna would add the plaque analysis to its nationwide coverage, effective in October. UnitedHealth previously decided to cover Heartflow's plaque analysis.

Write to Nicholas G. Miller at nicholas.miller@wsj.com.

(END) Dow Jones Newswires

September 22, 2025 16:41 ET (20:41 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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