Brisbane, Calif.-based Caption Health Inc. received good news from the U.S. FDA, which has given a thumbs up to Caption Guidance. This software aims to assist medical professionals in the acquisition of cardiac ultrasound images and uses artificial intelligence (AI) to provide real-time guidance.

Caption Guidance was reviewed by de novo pathway and is the first medical software authorized by the FDA that provides real-time AI guidance for medical imaging acquisition, the company noted. It emulates the guidance that an expert sonographer would provide to optimize the image.

Specifically, the software is indicated for use in ultrasound examination of the heart, known as two-dimensional transthoracic echocardiography, for adult patients in the acquisition of standard views of the organ from different angles. These views are used in the diagnosis of various cardiac conditions.

Days vs. years

In terms of getting health care professionals up to speed, the company told BioWorld that it only takes a few days to learn how to use Caption Guidance. With ultrasound, users require years of training.

Importantly, as Robert Ochs, deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, noted, the product could help health care professionals who may not be ultrasonography experts. “This is especially important because it demonstrates the potential for [AI] and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients,” he added.

The company also told BioWorld that contract discussions for purchase have begun, and it is eyeing the third quarter for shipping products. It added that it has not finalized pricing but will offer a subscription model.

“Working with the FDA has been an excellent experience,” the company said when asked about its interaction with the agency. “They demonstrated a sophisticated understanding of AI and its unique regulatory considerations throughout the process – they seem to completely understand the importance of our technology, and what it could mean for the future of ultrasound.”

When asked about additional plans for the next 12 to 18 months, the company said it foresees its offering “integrated onto additional hardware platforms and in the market with additional algorithms for guidance, quality, and interpretation.”

The Caption Guidance software currently can be used with a specific FDA-cleared diagnostic ultrasound system produced by Teratech Corp., with the potential to be used with other ultrasound imaging systems that have technical specifications consistent with the range of ultrasound systems used as part of the development and testing, the FDA noted.

Charles Cadieu, Caption Health co-founder and president, noted that the FDA’s actions demonstrate the company’s ability to pair breakthrough technology with strong clinical validation. “And we're just getting started."

Acute point-of-care settings, such as emergency and anesthesiology departments and critical care units, initially will have access to Caption Guidance. Plans are in place to expand to other departments.

"Point-of-care ultrasound has been demonstrated to expedite time to diagnosis, reduce the need for more costly testing, and decrease complications from invasive procedures," said John Bailitz, system point of care ultrasound education director, Northwestern Medicine. "Caption Guidance can unlock these benefits by addressing one of the largest barriers to ultrasound adoption: the ability to acquire diagnostic quality images quickly."

Data backing decision

The FDA made its decision following a review of performance testing, including data from a multicenter, prospective pivot clinical trial conducted by Northwestern Medicine and Minneapolis Heart Institute at Allina Health, evaluating the use of Caption Guidance by registered nurses with no ultrasound experience. Caption Guidance successfully met its primary endpoints, meeting the pre-specified criteria for study success.

Specifically, eight nurses used Caption Guidance to perform ultrasound exams on 240 patients, following a short training course. Patients were stratified to include a range of body-mass index and cardiac pathologies. They acquired limited echo exams of 10 views each. Exams were assessed by a panel of five expert cardiologists to determine if each was of sufficient quality to make a set of specific qualitative visual assessments.

The offering successfully met all four primary endpoints. Of note, the nurses successfully acquired limited echo exams for qualitative visual assessments of left ventricular size: 98.8%, 95% CI [96.7, 100]; left ventricular function: 98.8% [96.7, 100]; right ventricular size: 92.5% [88.1, 96.9]; and pericardial effusion: 98.8% [96.7, 100].

Word of the marketing authorization comes ahead of an FDA public workshop titled “Evolving Role of Artificial Intelligence (AI) in Radiological Imaging.” The agency is looking to discuss emerging applications of AI in radiological imaging, including AI devices intended to automate the diagnostic radiology workflow, as well as guided image acquisition. The workshop, which will be webcast, is scheduled for Feb. 25 and 26.

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