Icardio.AI

Market position

iCardio.ai positions itself as an AI supplier to the echocardiography workflow, competing on the scale of its training dataset, which it describes as making its core AI one of the largest-scale AI-based medical imaging products in the world. It has obtained FDA clearance for EchoMeasure and FDA Breakthrough Device Designation followed by 510(k) clearance for its CardioVision aortic stenosis tool, and was selected for the Cedars-Sinai Accelerator and profiled by the Roddenberry Prize.

The company emphasises the scale of its proprietary training data (200M+ ultrasound images across hundreds of thousands of de-identified patients), a breadth of dozens of production models covering measurement, disease detection and image quality rather than a single indication, FDA clearances and Breakthrough Device Designation, edge-deployable lightweight models for real-time guidance during scanning, and a distribution strategy based on embedding into existing PACS and ultrasound hardware.

Technology

The company trains deep learning models on a proprietary database of more than 200 million individual ultrasound images from hundreds of thousands of de-identified patients. Its model portfolio includes automated ejection fraction estimation, cardiac phase identification, automated linear and volumetric measurement, LVOT and aortic diameter measurement, structural and valvular disease detection from a single clip, image quality and completeness scoring, and an image-to-text description model. A compact feature-extraction and navigation model is designed to run on edge devices with limited computing power and in sub-par imaging conditions, providing real-time labelling of cardiac features during scanning and localising features to within 4 mm. Integration is offered through an API.

Go-to-market

iCardio.ai reaches clinicians through partnerships with PACS platforms and ultrasound equipment manufacturers, integrating its algorithms into their imaging workflows and exposing them via an API. It is live in the UltraLinQ PACS for educational and administrative uses, with additional PACS and hardware integrations listed as coming soon, and has joined Butterfly Network's Butterfly Garden AI marketplace to make its cardiac AI suite available to Butterfly's handheld ultrasound user base of more than 100,000 providers. Other announced commercial relationships include Viz.ai, SARC MedIQ PACS and Abbott, the latter focused on applying iCardio.ai algorithms to intracardiac echo images captured by Abbott catheters.

Ultrasound hardware manufacturers and PACS vendors (enterprise integration partners), health systems and accredited imaging institutions monitoring echo image quality, and clinicians and cardiologists performing or reading echocardiograms.

Geography

Headquartered in Los Angeles, California, with a stated aim of delivering its technology to clinicians globally through ultrasound and PACS partners.

History

The company was founded by Joseph Sokol, cardiologist Aakriti Gupta and Roman Sandler, with Joshua Penn also described as a co-founder; Sandler joined in 2022. In November 2023 iCardio.ai joined Butterfly Network's Butterfly Garden AI marketplace while its software was pending FDA clearance. During 2024 it announced partnerships with Viz.ai, SARC MedIQ and Abbott, joined the Cedars-Sinai Accelerator in September 2024, and received its first FDA clearance, for EchoMeasure, in October 2024. It subsequently received FDA Breakthrough Device Designation for CardioVision and, announced on November 24, 2025, a second 510(k) clearance for CardioVision for aortic stenosis.

Risks & controversies

Commercialisation depends on regulatory authorisation: the company's AI suite was marketed as pending FDA 510(k) clearance through 2023 and into 2024, and several distributor integrations remain listed as "coming soon" or limited to educational and administrative use rather than diagnostic use. Revenue reach is also tied to third-party PACS and ultrasound vendors that control the customer relationship.