FDA Breakthrough Device Designation for Precision Cirrhosis
The FDA granted Breakthrough Device status to Precision Cirrhosis, InVision's AI for opportunistic detection of end-stage liver disease from routine echocardiography. Early cirrhosis often mimics heart failure symptoms — fatigue, leg and abdominal swelling, poor appetite — and gets missed. Precision Cirrhosis aims to surface it during the standard cardiac exam, with a prospective multi-center validation trial funded by the American Heart Association.
Read release →FDA 510(k) clearance for InVision Precision Cardiac Amyloid
InVision received FDA 510(k) clearance for its AI Software as a Medical Device for detection of cardiac amyloidosis from apical-4-chamber and parasternal-long-axis echo views. The algorithm was previously granted Breakthrough Device Designation and enrolled in the FDA's Total Product Lifecycle Advisory Program (TAP). Peer-reviewed in JAMA Cardiology; developed with support from Alexion, AstraZeneca Rare Disease.
Read release →AMA adopts CPT billing code for Precision Cardiac Amyloid
The American Medical Association adopted a new Category III CPT code (0932T) covering AI adjunctive technologies for evaluating patients with heart failure symptoms. The code took effect January 1, 2025, providing a concrete reimbursement pathway for AI-assisted cardiac amyloidosis screening on echocardiography.
Read release →FDA 510(k) clearance for InVision Precision LVEF
InVision received FDA 510(k) clearance for automated evaluation of left ventricular ejection fraction from echocardiographic DICOM studies. Precision LVEF is the only AI echo product with published blinded, randomized prospective trial evidence (Nature, 2023) and was trained on the largest video dataset among FDA-cleared echo AI devices — with demonstrated time savings and improved consistency for both sonographers and cardiologists.
Read release →FDA Breakthrough Device Designation for the cardiac amyloidosis algorithm
The FDA granted Breakthrough Device Designation to InVision's AI for earlier identification of cardiac amyloidosis — a rare, underdiagnosed, and life-threatening condition. Unlike single-view approaches, the algorithm integrates information across multiple echocardiographic views to assess amyloid-associated features holistically, accelerating the regulatory pathway toward clinical deployment.
Read release →Multi-year AI collaboration with Alexion, AstraZeneca Rare Disease
InVision entered a multi-year agreement with Alexion to co-develop an AI algorithm for routine echocardiographic analysis — with the shared goal of accelerating earlier detection of patients with amyloidosis involving cardiac involvement. The partnership pairs InVision's echo AI expertise with Alexion's clinical footprint in rare disease.
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Our founders regularly speak to journalists on topics including AI in echocardiography, FDA regulatory pathways for Software as a Medical Device, and the economics of clinical AI deployment.