Heartvue.Proton

Trends

• Clinical AI moves into EHR platforms and reimbursement

Items

1. Sep 2

   FDA clears Heartvue.Proton with a change-control plan

   The 510(k) clearance covers an ML cardiac-MRI platform that automates dimensions, ventricular volumes, ejection fraction, and blood-flow quantification under physician review, with an authorized Predetermined Change Control Plan for bounded model updates.