InVision Precision Cardiac Amyloid
Overview
InVision Precision Cardiac Amyloid by InVision Medical Technology Corporation is an AI-powered software designed to aid clinicians in the evaluation of echocardiogram studies for cardiac amyloidosis, including both AL and ATTR types.
This tool is intended for use by cardiologists and other healthcare professionals in various care settings, particularly echocardiography laboratories within health systems.
The software integrates into existing clinical workflows by analyzing standard DICOM echocardiogram images (specifically apical-4-chamber and parasternal-long-axis views) as a post-processing analysis. It is designed to deploy alongside existing PACS, Epic EHR, and structured reporting platforms, without requiring new hardware or scanners. The aim is to flag patients with a high suspicion for cardiac amyloidosis for further consideration by clinicians, thereby assisting in earlier detection of a condition that can be underdiagnosed.
Notable capabilities include its FDA 510(k) clearance and its ability to analyze routine echocardiograms to identify potential cardiac amyloidosis. It was previously granted Breakthrough Device Designation by the FDA. A CPT Category III code (0932T), effective January 1, 2025, supports AI-assisted echocardiographic evaluation for patients with heart failure symptoms, which includes Precision Cardiac Amyloid.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered detection of cardiac amyloidosis
- Evaluation of transthoracic echocardiogram studies (apical-4-chamber and parasternal-long-axis view videos)
- Aids clinicians in diagnosing and assessing patients with heart failure symptoms
- Designed for earlier detection and reduction of misdiagnosis
- Supports both AL and ATTR Cardiac Amyloidosis
- Evidence-based AI algorithm, peer-reviewed and published in JAMA Cardiology
- Integration into clinical workflow
- Precise assessment of wall thickness in parasternal long axis view
- Computer vision risk assessment in apical 4 chamber view
- No racial bias in AI model output
Use Cases
- Diagnosing and assessing heart disease risk (specifically cardiac amyloidosis)
- Early detection of cardiac amyloidosis in patients with heart failure symptoms
- Streamlining interpretation of heart ultrasounds
- Identifying undiagnosed cardiac amyloidosis
- Aiding clinicians in busy echocardiography labs
- Personalizing treatment and prevention recommendations
What Physicians Need to Know
InVision Precision Cardiac Amyloid serves as a valuable adjunctive tool for the early identification of cardiac amyloidosis, a frequently underdiagnosed and life-threatening condition. Clinicians should integrate this AI-powered echocardiography analysis into their workflow, particularly for patients presenting with unexplained heart failure symptoms or individuals over 65 undergoing echocardiography. The tool can help prioritize patients for further confirmatory diagnostic testing, potentially leading to earlier intervention and improved patient outcomes. It is crucial to remember that this tool is an aid and should be used in conjunction with comprehensive clinical evaluation and other diagnostic modalities.
As an AI Software as a Medical Device (SaMD) for echocardiography, InVision Precision Cardiac Amyloid is designed for seamless integration into existing echocardiography workflows. This likely involves compatibility with standard echocardiography systems to process transthoracic echocardiogram studies. Future or current integrations may extend to Electronic Health Record (EHR) systems to facilitate automated flagging of suspicious cases and streamline patient management and follow-up.
Details
| Category | Cardiology AI |
| Pricing | Subscription — Starting at $49/mo; Contact InVision Medical Technology for enterprise pricing and volume discounts. |
| Deployment | Software as a Medical Device (SaMD), integrated into clinical workflows for echocardiography labs. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated InVision Precision Cardiac Amyloid received US FDA 510k clearance (K243866) on May 21, 2025, as an AI Software as a Medical Device (SaMD) for echocardiography for the detection of cardiac amyloidosis. It had previously received US FDA Breakthrough Device Designation. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Radiology |
What the Web Says
InVision Precision Cardiac Amyloid is an AI-powered software as a medical device (SaMD) designed to detect cardiac amyloidosis from echocardiogram videos, particularly in patients aged 65 and over. It aims to address the challenge of underdiagnosis of this life-threatening condition by flagging individuals at high suspicion for further investigation. The device has received FDA 510(k) clearance and Breakthrough Device Designation, with a CPT Category III code effective January 1, 2025, supporting reimbursement.
Overall: PositiveStrengths
- Aids in early detection of cardiac amyloidosis, a condition often missed and now treatable.
- Utilizes AI to analyze routine echocardiograms, integrating into existing workflows with zero marginal clinician burden.
- Backed by extensive academic research and peer-reviewed publications in journals like Nature and JAMA Cardiology.
- FDA 510(k) cleared and received Breakthrough Device Designation, indicating regulatory confidence.
- Reimbursement is supported by a CPT Category III code (effective Jan 1, 2025) and New Technology Add-On Payment (NTAP) for inpatient settings.
- Shown to reduce sonographer and cardiologist effort while improving measurement consistency in related InVision products.
Limitations
- Patient management decisions should not be made solely on the results of the InVision Precision Cardiac Amyloid.
- Limited information available from independent tech reviewers, G2, Capterra, or extensive Reddit discussions specifically on this product, making a comprehensive external sentiment analysis challenging.
- While AI tools show promise, challenges to broader adoption include usability, cost, value added, EHR/IT interoperability, and patient-related factors.
- Some AI models for cardiac amyloidosis have shown a drop in specificity, which could lead to false positives.
- Further model refinement and validation in more diverse populations are required to expand integration into clinical practice and enhance generalizability.
Based on reviews from: InVision Medical Technology, Intentional Intelligence (David Ouyang, InVision founder), FDA, MEARIS, Reddit, PMC (PubMed Central), MDPI, MedPage Today
Last updated: 2026-07-19
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate InVision Precision Cardiac Amyloid
Press & Coverage
Videos
Product demos, reviews, and walkthroughs for InVision Precision Cardiac Amyloid.
Frequently Asked Questions
Compare InVision Precision Cardiac Amyloid
VS
VS
VS
VS
