March 5, 2020 — Caption Health, a medical AI company, announced that its flagship product, Caption AI, the first AI-guided medical imaging acquisition system, is now available for pre-order by healthcare providers. Caption AI is a transformational new technology that enables healthcare practitioners—even those without prior ultrasound experience — with the ability to perform ultrasound exams quickly and accurately, by providing expert guidance, automated quality assessment, and intelligent interpretation capabilities.
Caption AI comes equipped with Caption Guidance software, which uses artificial intelligence to provide real-time guidance and feedback on image quality to enable capture of diagnostic quality images. This announcement follows the recent groundbreaking marketing authorization of Caption Guidance software by the U.S. Food and Drug Administration (FDA). The safety and effectiveness of Caption Guidance was clinically validated in a multi-center prospective pivotal trial at Northwestern Medicine and Minneapolis Heart Institute at Allina Health with registered nurses with no prior ultrasound experience. Data on its effectiveness has been presented at conferences including the American Heart Association and the American Society of Echocardiography (ASE) Scientific Sessions. Full results of this study will be published in a peer-reviewed journal.
Caption AI also comes with FDA cleared automated interpretation capabilities. Caption Interpretation automatically reviews the clips from an exam, rates them according to image quality, and selects the best ones to calculate the patient's ejection fraction (EF), the most widely used measurement to assess cardiac function. The software was trained on a carefully curated dataset of over 4,000,000 images, representing 9,000 patients. Results from a study evaluating the effectiveness of Caption Interpretation were presented at the ASE Scientific Sessions, and concluded that the fully automated ejection fraction algorithm was accurate, performing well on patients across a range of body-mass index (BMI) and EF, including obese patients and on patients with a range of normal and abnormal EF.
Caption AI was developed to empower more clinicians with ultrasound image acquisition capability to bring the benefits of ultrasound to more patients, help standardize the quality of care, and help institutions realize valuable cost and time savings. The system is ideal for acute point-of-care settings, including emergency rooms, anesthesiology departments, and critical care units. 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. Caption AI is a software solution that can be integrated onto compatible ultrasound devices and is offered through a subscription pricing model. Caption Health is now offering pre-orders of Caption AI to accredited United States healthcare providers for use with adult patients for delivery in Q3. Visit captionhealth.com to pre-order.
September 11, 2025 
