Amid a growing number of devices use AI to instruct users but Caption Health says its software is the first that helps clinicians perform echocardiograms.
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. In one, 50 trained sonographers scanned patients with and without Caption Guidance, capturing diagnostic quality images in both scenarios. The second study examined the software’s use by eight registered nurses who were not experts in sonography. The nurses were able to capture diagnostic-quality echocardiograpy images and videos, as determined by five cardiologists.
The FDA reviewed Caption Guidance through its De Novo premarket review pathway, which covers low- to moderate-risk devices of a new type. In addition to authorizing the software, the FDA also said it was creating a new regulatory classification under which similar devices could obtain marketing authorization as long as they can demonstrate “substantial equivalence to a predicate device,” provided they meet certain other requirements.
Caption Health – founded in 2013 and formerly known as Bay Labs – is working with health systems to make the software available this summer, Charles Cadieu, the company’s president and co-founder, said in a phone interview. Caption Guidance is the company’s first product to be commercialized.
“We’re definitely excited by this milestone,” Cadieu said. The company’s CEO is Andy Page, former president and board member of DNA testing company 23andMe.
Other devices embed AI to guide their users. Digital stethoscope maker Eko, for example, recently won FDA clearance for AI that helps frontline clinicians better detect heart murmurs and atrial fibrillation. The agency also recently cleared a smart cap – developed by startup Cognita Labs – that fits over asthma inhalers and instructs patients on proper use.
Caption Guidance, though, is the first to help in the acquisition of cardiac ultrasound images, or echocardiography, Cadieu said. With Caption Guidance, he said, “More doctors can perform these exams and then more patients have access.”
Sonographers undergo extensive training to capture images and they refine their techniques through extensive practice. Caption Health spent years replicating that expertise in its software, Cadieu said.
“The AI starts to know, just from looking at ultrasound imagery where the operator needs to move their hands to get from a non-diagnostic image to a diagnostic image,” Cadieu said.
However, Caption Guidance is not designed to replace sonographers, Cadieu said. Instead, the software will allow other clinicians to be more effective gatekeepers, sending the most complex cases to sonographers while speeding up care for patients.
Emergency room doctors, for example, could use Caption Guidance to quickly assess patients who come in with chest pains, a potential sign of a heart attack.
Patients may still need additional sonography, Cadieu said. But, he added, if ER doctors “determine that the patient has reduced cardiac function, for example, they can accelerate a referral to cardiology or other doctors.”
Caption Health recently won notice from a top physician who advocates for the digital transformation of medicine – Dr. Eric Topol, cardiologist, geneticist and author. Topol is the founder and director of the Scripps Research Translational Institute in La Jolla, California.
Source: MedCity News