Heartvue.ai and Innolitics Gain FDA Clearance for Cardiac MRI AI

Brentwood, Tennessee & Austin, Texas, USA, September 3, 2026

Heartvue.Proton Automates Cardiac MRI Measurements

Cardiac MRI provides detailed information about cardiac structure and function, but quantitative analysis can require substantial manual effort. According to the companies, analysis of an individual study can take up to an hour or longer, creating workflow challenges as demand for quantitative cardiac imaging increases. Heartvue.Proton is designed to automate measurements across three major areas: 2D linear dimensions, ventricular volumes and ejection fraction, and blood-flow quantification. By handling repetitive post-processing tasks, the software is intended to allow physicians to spend more time on image interpretation and clinical decision-making. Heartvue says the platform produces automated measurements while keeping the physician responsible for reviewing and controlling the results before they are used clinically. The technology is also designed for integration into existing clinical infrastructure rather than requiring hospitals to establish an entirely separate imaging workflow. Heartvue.Proton can connect with hospital PACS and EHR environments, supporting the movement of imaging information and quantitative results through established systems. Heartvue’s platform is focused specifically on cardiovascular imaging, with its current product portfolio addressing cardiac MRI automation and echocardiography workflow support.

FDA Clearance Includes AI Change Control Plan

A notable aspect of the regulatory milestone is that the FDA 510(k) clearance includes an authorized Predetermined Change Control Plan (PCCP). For AI-enabled medical devices, a PCCP can establish a regulatory framework for specified future modifications to machine-learning models without requiring a new 510(k) submission for every change, provided those modifications remain within the predefined boundaries accepted by the FDA. This capability can be particularly important for software that may evolve as additional clinical data become available. For Heartvue.ai, the PCCP is intended to support controlled improvements to its machine-learning models within predefined parameters. The companies said the regulatory pathway incorporated work covering FDA Pre-Submission preparation, clinical validation study design, AI/ML documentation, cybersecurity documentation and PCCP development. Innolitics supported Heartvue through the regulatory lifecycle, including interactions with the FDA. The 510(k) was cleared approximately five and a half months after submission, according to the announcement.

Heartvue.ai Prepares U.S. Commercial Rollout

Following the FDA clearance, Heartvue.ai plans to begin commercial rollout of Heartvue.Proton to U.S. hospitals and imaging centers, building on an existing beta-site network. The company was founded by cardiologist Jeffrey Dendy, MD, and focuses on applying artificial intelligence to cardiovascular imaging workflows. Its broader technology strategy is aimed at reducing repetitive imaging tasks, improving reporting consistency and supporting more efficient cardiovascular imaging operations. The clearance also illustrates the growing regulatory focus on AI and machine-learning medical devices in diagnostic imaging. For cardiovascular imaging providers, automated measurement of ventricular function, dimensions and blood flow could help standardize quantitative analysis while reducing the time required for manual post-processing. However, the FDA clearance does not mean that artificial intelligence replaces physician interpretation; Heartvue.Proton is designed to operate with qualified clinician review and oversight. For medical imaging AI, the combination of FDA clearance and an authorized PCCP provides an important example of how developers can prepare machine-learning software for controlled evolution after regulatory authorization. As Heartvue.ai moves toward commercial deployment, adoption by hospitals and imaging centers will provide further insight into how automated cardiac MRI analysis can affect workflow efficiency, reporting and quantitative cardiovascular imaging. The milestone positions Heartvue.Proton as a newly FDA-cleared tool within the expanding field of AI-enabled cardiac imaging and digital health technology.

Source: Heartvue.ai, Innolitics press release