FDA Approves AI Software from Cardiologist-Founded Company
Tennessee-based medical technology company Heartvue.ai has received clearance from the US Food and Drug Administration for its new AI-powered software that analyzes cardiac MRI scans.
Heartvue.ai, founded by cardiologists, has announced that it received clearance from the U.S. Food and Drug Administration (FDA) for its new AI-powered software, Heartvue.Proton, which images, processes, and evaluates cardiac MRI scans.
Software Approval Process
Tennessee-based medtech company Heartvue.ai has successfully completed the regulatory approval process for its new AI-powered imaging software that processes cardiac MRI scans. Austin-based consulting firm Innolitics guided the company through this process.
AI-Powered Measurements
Named Heartvue.Proton, the new software utilizes advanced artificial intelligence algorithms to automate measurements of 2D linear dimensions, ventricular volumes, ejection fraction, and blood flow quantification.
Integration into Clinical Workflow
While automating measurements provides significant time savings, each resulting output continues to be reviewed and validated by a trained clinician. The software can seamlessly integrate with hospital systems.
Future Plans and Updates
The approval process also included a Predetermined Change Control Plan, which allows the company to make certain updates to the software without submitting additional applications to the FDA. Co-founder Dr. Jeffrey Dendy evaluated the development, and plans for commercial rollout were also announced.