![]() 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. “Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”įDA’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. “No patient should have to forgo a potentially life-saving cardiac ultrasound,” said Andy Page, chief executive officer of Caption Health. 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. Caption Guidance is equipped with numerous features that together act as a co-pilot for clinicians when performing an ultrasound exam. 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. 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.Ĭaption Guidance was authorized via the De Novo pathway, a regulatory pathway reserved for novel technologies. 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. Food and Drug Administration (FDA) authorized marketing of Caption Guidance, software that assists medical professionals in the acquisition of cardiac ultrasound images. FDA Grants Caption Health Landmark Authorization for First AI-Guided Image Acquisition System Caption Guidance™ uses artificial intelligence to empower medical professionals without specialized training to perform cardiac ultrasound.īRISBANE, CA – Febru– Caption Health, a leading medical AI company, announced today that the U.S. ![]()
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