FDA Approves New AI Cardiac Imaging Tools From Heartvue And Philips

Federal health regulators have cleared a trio of new artificial intelligence software solutions designed to enhance cardiac and oncological imaging workflows, marking a significant advancement for automated diagnostic tools in hospital settings. The U.S. Food and Drug Administration granted 510(k) clearance to Tennessee-based medtech startup Heartvue.ai for its cardiac MRI processing platform, alongside separate clearance for a real-time procedural guidance tool developed by Royal Philips and Edwards Lifesciences.

The regulatory approvals arrive as hospitals nationwide grapple with growing demands for diagnostic imaging against a backdrop of severe staffing constraints and mounting procedural backlogs. By integrating advanced machine learning directly into existing Picture Archiving and Communication Systems and Electronic Health Record workflows, the newly cleared technologies aim to automate tedious measurements and streamline complex interventions without replacing the ultimate judgment of trained medical professionals.

Heartvue.ai received FDA clearance for its flagship platform, Heartvue.Proton, which automates routine measurements of 2D linear dimensions, ventricular volumes, ejection fraction, and blood flow quantification. The Tennessee-based company was founded by practicing cardiologists seeking to reduce the hours clinicians spend executing manual quantitative evaluations on cardiac resonance scans. Guidance through the regulatory submission was supported by Austin-based consulting firm Innolitics.

The software package includes a Predetermined Change Control Plan, a regulatory mechanism allowing the company to deploy specific software updates without submitting subsequent clearance requests to the agency. “As a practicing cardiologist, I built Heartvue.Proton to give clinicians back the time they spend on manual measurements and to make quantitative cardiac MRI available to every patient who needs it,” Jeffrey Dendy, MD, Heartvue.ai co-founder and an assistant professor of cardiovascular medicine at Vanderbilt University Medical Center, said in a statement. Heartvue.ai is preparing for a commercial rollout while maintaining a secondary echocardiography offering, Heartvue.Echo.

In a separate regulatory action, Royal Philips announced FDA 510(k) clearance for its EchoNavigator R5.0 featuring DeviceGuide, an AI-powered tool developed in close collaboration with Edwards Lifesciences. Designed for mitral transcatheter edge-to-edge repair procedures, the software tracks and visualizes the Edwards PASCAL Ace mitral valve repair device in real time by fusing live ultrasound from Philips EPIQ CVxi platforms with live X-ray fluoroscopy from Azurion systems.

Mitral regurgitation affects more than 35 million adults globally and over two million in the United States, requiring interventionalists and echocardiographers to interpret multiple screens simultaneously during delicate catheterizations. DeviceGuide provides a visual overlay, trajectory line, and orientation indicators directly onto the imaging screen. “Since AI auto-aligns imaging to the device in real time and continuously informs the interventionalist about the location of the device in space on the imaging screen, it minimizes unnecessary repositioning of the imaging window, streamlines procedural guidance and may improve the precision of device implantation,” said Rebecca T. Hahn, MD, director of interventional echocardiography at NewYork-Presbyterian/Columbia University Irving Medical Center.

The integration of assistive artificial intelligence into high-stakes cardiology environments has raised important questions regarding operator control and workflow disruption. Manufacturers and clinical investigators emphasize that the software functions strictly as an assistive copilot rather than an autonomous decision-maker, ensuring that attending physicians retain absolute authority over therapeutic interventions.

“The AI software serves as an assistive tool; the physician always remains in control. This isn’t about replacing expertise—it’s about amplifying it,” explained Dr. Atul Gupta, Chief Medical Officer of Diagnosis and Treatment at Philips. By presenting real-time target, orientation, and auto-device-aligned views on a unified display, the technology reduces the need for constant communication between separate equipment operators, thereby lowering procedural friction in high-volume cath labs.

Beyond cardiovascular applications, the regulatory landscape has seen broader clearances for image acceleration and enhancement software designed to alleviate bottlenecks in nuclear medicine and oncology. Subtle Medical announced FDA clearance for its SubtleHD PET imaging enhancement solution, which is engineered to improve quantitative accuracy and image reconstruction quality across PET/CT and PET/MR systems while accelerating scans by up to 75%.

“PET imaging demand continues to grow globally, but providers remain constrained by scanner capacity, long scan times and operational inefficiencies,” said Ajit Shankaranarayanan of Subtle Medical. The software supports all FDA-approved radiotracers and leverages anatomical computed tomography data to refine low-count acquisitions. Shorter scan times directly benefit vulnerable populations—such as pediatric, elderly, and critically ill oncology patients—who frequently struggle with extended acquisition windows, while simultaneously enabling imaging centers to increase daily patient throughput and revenue.