Introducing Precision Cardiac Amyloid

Evidence driven AI echocardiography diagnostic aid for detecting cardiac amyloidosis

We are very excited to announce that InVision Precision Cardiac Amyloid AI has been US FDA 510k cleared! This AI Software as a medical device can aid clinicians in the evaluation of echocardiogram studies for both AL and ATTR Cardiac Amyloidosis, a condition where abnormal proteins deposit into heart muscle leading to electrical abnormalities and heart failure.

We’re proud to say Precision Cardiac Amyloid is one of the most evidence based echocardiography AI algorithms, with:

1. Original preprint in 2021

2. First paper published in JAMA Cardiology in 2022

3. Further validation showing no racial bias in AI model output

4. Confirmation of accuracy in clinical trial data from NEURO-TTRansform

5. International confirmation of model performance across many centers

6. Ongoing prospective multi-center clinical trial funded by Kaiser Permanente and the Gordon and Betty Moore Foundation

Starting from an academic research program, Precision Cardiac Amyloid underwent four years of rigorous testing, received the US FDA’s Breakthrough Designation, and Total Product Lifecycle Advisory Program (TAP). Given our priority for open-science and rigorous testing of AI models, the research model was one of first echo AI algorithms to have publicly available weights and code in the public domain.

InVision Precision Cardiac Amyloid tackles the challenges of busy echocardiography labs - highlighting individuals at high suspicion for cardiac amyloidosis. A key bottleneck in the diagnosis of cardiac amyloid is the referral for additional imaging and further testing, however this requires careful vigilance for a rare disease.

Echocardiography is the most common form of cardiac imaging, so patients with shortness of breathe, volume overload, palpitations, or even no symptoms at will all often undergo echocardiography. InVision Precision Cardiac Amyloid flags patients at high suspicion for CA for further consideration by clinicians. InVision Precision Cardiac Amyloid is the only FDA cleared diagnostic aid for cardiac amyloidosis even before they have heart failure symptoms. Due to it’s optimized specificity, Precision Cardiac Amyloid is cleared for all individuals greater than 65 years old who undergo echocardiography.

I’ve mentioned this on the NEJM AI podcast, but I think of AI detection of cardiac amyloidosis is a perfect use-case for AI, with synergy of interests between patients, clinicians, and life science companies. Currently, there is a bottleneck in diagnosis (cardiac amyloidosis infrequent enough that clinical recognition is challenging), such that effective, evidence based AI solutions can be transformative. At the same time, cardiac amyloidosis management has undergone tremendous advances in recent years with multiple new highly efficacious treatments for both ATTR and AL amyloidosis. This life threatening and previously untreatable disease how has many options for management, provided patients can receive early and accurate diagnosis.

An end-to-end solution, Precision Cardiac Amyloid runs through the following steps:

1. Processes transthoracic echocardiogram studies, evaluating all videos for view classification and image processing.

2. Conduct precise assessment of wall thickness in the parasternal long axis view.

3. Conduct computer vision risk assessment in the apical 4 chamber view.

4. Synthesizes the combination of texture and wall thickness information to provide adjunctive information on the suspicion of cardiac amyloidosis.

Contact the InVision team if you’d like more information on how to deploy Precision Cardiac Amyloid in your clinical workflow.