Updated clearance for AI-based software may aid cardiac diagnoses in COVID-19
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Caption Health announced that the FDA issued an updated clearance for its artificial intelligence-guided image acquisition system for use with cardiac ultrasound, which has the potential to minimize caregiver contact with patients with known or suspected COVID-19.
As Healio previously reported, the software (Caption Guidance), an accessory to compatible diagnostic ultrasound systems that uses AI to obtain diagnostic-quality pictures of the heart, was initially cleared by the FDA in February.
The updated clearance is for a new version that offers more types of guidance, improved algorithm performance and optimized workflow, which could enable rapid diagnosis of cardiac function while reducing the exposure between hospital personnel and patients, according to a press release from the company.
The technology allows clinicians without specialized echocardiography training to capture images at the point of care, in accordance with recommendations from the American Society of Echocardiography on reducing risk for exposure to the SARS-CoV-2 and conserving use of personal protective equipment, according to the release.
“This is a valuable add-on that improves the current technology,” Robert McNamara, MD, MHS, associate professor of medicine (cardiovascular medicine) at Yale University School of Medicine, told Healio. “To be able to teach somebody how to do ultrasound is a very difficult process that often takes months, if not years, of practice. The new release is more intuitive, which is key for the performers to acquire the appropriate images.”
According to the release, the FDA review took just 25 days and was initiated after urgent requests from physicians detailing how the new system could help in the care of patients with COVID-19, many of whom have preexisting CV conditions and/or cardiac effects from COVID-19.
“This pandemic has increased considerably the demand for point-of-care ultrasound within the hospital,” McNamara told Healio. “The number of patients who need ultrasound at the bedside has increased exponentially during this time. More people are learning how to do this procedure, but some are not as confident as they need to be, and this will help with that. Also, this could reduce the amount of personal protective equipment that is needed. Usually, multiple people participate in the test, but obviously this is not ideal with COVID-19. Having one person be able to go in and see the patient and perform the scans to a confident level is extremely valuable.” – by Erik Swain
For more information:
Robert McNamara, MD, MHS, can be reached at Cardiovascular Medicine, P.O. Box 208017, 333 Cedar St., New Haven, CT 06520.
Disclosure: McNamara reports no relevant financial disclosures.
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