FDA OKs first-of-a-kind AI that guides cardiac imaging - MedCity News

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.