BRISBANE, Calif.—Caption Health, Inc. has announced that the U.S. Food and Drug Administration (FDA) has authorized marketing of Caption Guidance. Caption Guidance software assists medical professionals in the acquisition of cardiac ultrasound images by using artificial intelligence (AI) to provide real-time guidance and diagnostic quality assessment of images. This reportedly allows healthcare providers — even those without prior ultrasound experience — with the ability to capture diagnostic quality images.
“No patient should have to forgo a potentially life-saving cardiac ultrasound,” said Andy Page, chief executive officer of Caption Health. “Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”
Caption Guidance is the first FDA-approved medical software that provides real-time AI guidance for medical imaging acquisition. Caption Guidance is equipped with numerous features that act as a co-pilot for clinicians when performing an ultrasound exam. The software emulates the guidance that an expert sonographer would provide to optimize the image, including providing real-time guidance on how to manipulate the transducer, and automated feedback on diagnostic image quality.
The FDA’s authorization of Caption Guidance comes at a time when democratization of ultrasound is touted as the future of healthcare due to portable form factors and increasing hardware affordability. Ultrasound is a safe, non-invasive and powerful diagnostic tool, and its benefits to patients have been demonstrated in a variety of clinical settings, from the emergency department to the operating room. But performing ultrasounds can be challenging, and requires specialized training to master.
“We founded Caption Health to tackle head-on some of the most challenging, intractable problems in medicine. This FDA authorization confirms our unique ability to couple breakthrough technology with robust clinical validation. And we're just getting started,” noted Charles Cadieu, co-founder and president.
Caption Health initially plans to deploy Caption Guidance in acute point-of-care settings, including emergency and anesthesiology departments, and critical care units. These settings serve a high volume of patients, and ultrasound can be used to triage, monitor and assess patients who have chest pain, shortness of breath, cardiac arrest and many other conditions, as well as for the detection of heart disease.
“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,” added Dr. 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.”
Marketing authorization was granted after the FDA reviewed extensive performance testing, including data from a pivotal multi-center prospective clinical trial conducted by Northwestern Medicine and Minneapolis Heart Institute at Allina Health, which evaluated the use of Caption Guidance by registered nurses (RNs) with no prior ultrasound experience. Caption Guidance successfully met its primary endpoints, meeting the pre-specified criteria for study success.
In the study, eight RNs with no prior ultrasound experience used Caption Guidance to perform ultrasound exams on 240 patients, following a short training course. Patients were stratified to include a wide range of body-mass index and cardiac pathologies. The RNs acquired limited echo exams of 10 views each. Each exam was assessed by a panel of 5 expert cardiologists to determine if the exam was of sufficient quality to make a set of specific qualitative visual assessments.
Caption Guidance successfully met all four primary endpoints, meeting the pre-specified criteria for study success by acquiring images of sufficient quality for specific clinical assessments. The RNs 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].
“Throughout the process, the FDA demonstrated a sophisticated understanding of AI and its unique regulatory considerations. It has been a privilege to collaborate with the Agency on the development of a new regulatory paradigm for AI-guided image acquisition,” concluded Sam Surette, head of RA & QA at Caption Health.