First FDA-Authorized AI Cardiac Ultrasound Software: Regulatory Strategy for Innovation and Access

1. Background and Mission

A pioneering effort aims to help detect diseases early—when there is the highest potential for impact—by leveraging AI and ultrasound. It is a team of entrepreneurs, engineers, and clinicians committed to transforming care, expanding access, and reducing costs.

2. The Opportunity

Echocardiograms are one of the most widely used diagnostic tools for heart disease. They are typically performed by cardiac sonographers, who require multiple years of training. Today, there is a shortage of diagnostic and medical sonographers in the US. The opportunity was seen to build a novel product to assist medical professionals in acquiring cardiac ultrasound images.

3. The Challenge

Innovative cardiac AI-enabled software products can pose unique regulatory challenges. It was important to ensure product safety and effectiveness while embracing the iterative nature of AI-based software as a medical device. To account for forthcoming product changes upfront, target user populations were identified, along with the product's fit within existing and potentially future clinical pathways, and other impacts to inform the intended use.

4. The Approach

Options for engaging with the FDA were identified, which included a series of pre-submission meetings (including a physical demo of the software during a face-to-face meeting) and applying for breakthrough designation status, given the novelty of the product. Using the De Novo pathway, the first regulatory approval for a predetermined change control plan (PCCP) was obtained, which allows manufacturers to make specific changes to a product without a new regulatory submission. The PCCP was used to port the software to new hardware platforms and optimize product algorithms without additional regulatory submissions, thus saving time and money.

5. The Success

The first FDA-authorized cardiac ultrasound AI software clearance was received under the FDA's breakthrough program. The breakthrough designation status opened reimbursement pathways with the Centers for Medicare & Medicaid Services (CMS) – enabling a new technology add-on payment (NTAP) designation. Following the regulatory and reimbursement successes, the technology was integrated with advanced ultrasound devices to bring it to more patients across the globe. Combining AI applications with ultrasound devices will help accelerate the mission to detect disease earlier when an easily obtained diagnostic image can be a great equalizer to health quality and outcomes to ultimately help reduce costs and enhance care.