Caption Health Secures FDA Autho­riza­tion for First-in-Class AI-Guided Medical Ultrasound

Ultrasound is a ubiquitous technology to diagnose patients. From prenatal care to your heart, lungs, and liver, ultrasound is the standard of care for under­standing the function of many internal organs of the body. But it’s not easy to do. As a result, there are many clinical settings – including the emergency room, critical care settings, heart failure clinics, and others – for which a high quality ultrasound is needed but not used because there aren’t enough profes­sionals who have the skills or experience to an ultrasound.

Today, the FDA granted De Novo FDA autho­riza­tion for a new device under its Break­through Device program. That device, DCVC portfolio company Caption Health’s lead product, Caption Guidance, uses artificial intel­li­gence (AI) to put the power of ultrasound in the hands of a wide range of healthcare profes­sionals – even those without any prior ultrasound experience. A nurse simply places a probe on the patient’s chest, and the product gives turn-by-turn directions to the view requested by the physician. When a diagnostic-quality image has been captured, a meter lights up and the best image clip is auto­mat­i­cally saved – without the user even having to press a button.

As few as 12 Break­through devices have been cleared or approved in the history of the program, and this is the first FDA clearance for an AI-guided medical imaging acquisition system. The clearance grants that Caption Guidance can be used on any hardware to capture ultrasound images of clinical diagnostic quality – even when used by non-physician health profes­sionals like nurses or nurse prac­ti­tioners. By giving this diagnostic power to medical profes­sionals of all types, patients can receive care faster, creating better outcomes for everyone. This is reinforced by the rare public announce­ment from the FDA of Caption Guidance’s De Novo clas­si­fi­ca­tion. Caption Guidance will be used for imaging of the heart, and the company plans to offer products to image other organs, as well.

The FDA deems a Break­through Device to be one that is novel, has no alter­na­tives and deemed by the FDA to ​“provide more effective diagnosis for life-threatening or irre­versibly debil­i­tating diseases.” The FDA created an entirely new clas­si­fi­ca­tion for Caption in this clearance via the De Novo regulatory pathway.

The company worked closely with the FDA to provide evidence for its claim that nurses could capture images of diagnostic quality. Eight nurses with no prior ultrasound experience in two different insti­tu­tions (The Minneapolis Heart Institute and North­western University Medical Center in Chicago) performed 30 scans each for a total of 240. For each of four different clinical assessments, the FDA wanted to see that 80% of the images obtained by nurses using Caption were of diagnostic quality. Trained ultrasound technicians did those assessments in the same patients to ensure that the evaluating cardi­ol­o­gists were blinded as to which scans came from whom. Patients had a wide range of body mass indices (BMI) and comor­bidi­ties, so as to include a range of difficulty levels in obtaining a scan. In fact, some patients were so sick that they couldn’t stay awake for the few minutes it took to perform the procedure. Expert cardi­ol­o­gists, blinded as to which images came from whom, determined which scans were suitable for core clinical assessments frequently performed at the point of care.

The results were stunning. For three of the different clinical assessments, nurses using Caption obtained diagnostic-quality exams 98.8% of the time. For the fourth, nurses obtained a diagnostic-quality exams 92.5% of the time.