Caption Health, a leading medical AI company, announced that the US Food and Drug Administration (FDA) authorized marketing of Caption Guidance, software that assists medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance uses artificial intelligence to provide real-time guidance and diagnostic quality assessment of images, empowering healthcare providers—even those without prior ultrasound experience—with the ability to capture diagnostic quality images. Empowering more clinicians with ultrasound image acquisition capability will bring the benefits of ultrasound to more patients, help standardize the quality of care, and help institutions realize valuable cost and time savings. Caption Guidance was authorized via the De Novo pathway, a regulatory pathway reserved for novel technologies. The granting of this De Novo is groundbreaking, as Caption Guidance is the first medical software authorized by the FDA that provides real-time AI guidance for medical imaging acquisition. Caption Guidance is equipped with numerous features that together 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. "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." 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. However, performing ultrasound is challenging and requires specialized training to master, which prevents its adoption and can compromise quality and care. "We founded Caption Health to tackle head-on some of the most challenging, intractable problems in medicine," said Charles Cadieu, co-founder and president. "This FDA authorization confirms our unique ability to couple breakthrough technology with robust clinical validation. And we're just getting started." Caption Guidance will initially be deployed in acute point-of-care settings, including emergency and anesthesiology departments and critical care units, with plans to expand to additional departments. These settings serve a high volume of patients; emergency rooms alone are visited by one in five US adults at least once per year. In these environments, 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," said 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, evaluating 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 this 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. Namely, 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]. In 2018, the FDA granted Breakthrough Device designation to Caption Guidance. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet additional criteria including being a breakthrough technology with no approved alternatives and offers significant advantages over existing alternatives. "Throughout the process, the FDA demonstrated a sophisticated understanding of AI and its unique regulatory considerations," said Sam Surette, head of RA & QA at Caption Health. "It has been a privilege to collaborate with the Agency on the development of a new regulatory paradigm for AI-guided image acquisition." In addition to Caption Guidance, Caption Health's full software suite includes automated interpretation and quality assessment capabilities, to assist clinicians throughout their workflow. Caption Guidance software can be integrated onto compatible ultrasound devices. It will be paired with Caption Health's automated ejection fraction interpretation capability and will be offered to the market as Caption AI.