"I would love to see a future where looking inside the body becomes as routine as a blood pressure cuff measurement," says Charles Cadieu '04, MEng '05. As president of the medical technology startup Caption Health, he sees that future in reach--with the help of artificial intelligence. Cadieu still remembers the "lightbulb moment" during his postdoctoral research at MIT when he realized that the field of AI would never be the same. He was working in the lab of James DiCarlo (now the Peter de Florez Professor of Neuroscience) on neural networks--AI systems made up of deep-learning algorithms that emulate the dense networks of neurons in the brain. Until then, neural networks had been unable to perform even simple visual tasks that the brain handles with ease.

The FDA has cleared what it describes as the first software that uses AI to guide family doctors, registered nurses and other clinicians in taking cardiac ultrasounds. Developed by Brisbane, California-based Caption Health, the software communicates instructions via prompts on a screen-based interface. The prompts allow non-experts to capture images and videos of diagnostic quality. "This is especially important because it demonstrates the potential for artificial intelligence and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients," Robert Ochs, a deputy director in the FDA's Center for Devices and Radiological Health, said in a statement. The software is called Caption Guidance and was cleared for use with a diagnostic ultrasound system developed by Teratech Corp., though the software has the potential to be used with other systems, according to the FDA. In granting clearance to the software, the agency said it looked at two independent studies.

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.