Public source

Reviewed 2 Oct 2026

Completeness Fair (31%)

Heart.AI

LARALAB

Heart.AI is a cloud-based software application that automatically analyses cardiac CT images to support the planning of structural heart interventions. It segments cardiac structures, including the aortic, mitral and tricuspid valves and the cardiac chambers, and provides anatomical measurements to assist clinicians in procedure planning and device sizing.

No papers to support — we monitor for new evidence.

General Information

Product name

Heart.AI

Company

Modality

CT

Main task

Autosegmentation

Subspeciality

Cardiac

Disease targeted

Not specified

Regulatory Information

CE Certification

Pathway:

MDR

Class:

Class IIb

Not verified by Health AI Register

FDA Certification

Pathway:

510(k) cleared

Class:

Class II

FDA Number:

Verified by Health AI Register

Other certifications

Not specified

Evidence & Research

No research papers or evidence on file yet.

The registry monitors publications for new evidence.

Technical Specifications

Patient population age

Not specified

Input

Not specified

Input format

Not specified

Output

Not specified

Output format

Not specified

Integration

Not specified

Deployment

Not specified

Trigger for analysis

Not specified

Processing time

Not specified

Population

Not specified

Market Presence

On market since

Not specified

AI Platforms

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Not specified

Based on

Not specified

Source: Public | First published: Oct 2, 2026 | Last updated: Oct 2, 2026