FDA grants ‘breakthrough’ designation to ultrasound AI product

Software that uses AI to make cardiac-ultrasound experts of healthcare workers with no prior ultrasound experience has received “Breakthrough Device” designation from the FDA.

The technology, called Caption Guidance, is a rebranded version of EchoGPS, which was marketed by Bay Labs. Along with the product renaming, the company has changed its name to Caption Health.

The software enables nurses and other nonphysician healthcare workers to not only acquire and quality-check echocardiograms but also provide initial image interpretations, all with an assist from AI.

The FDA’s recognition of the product’s innovativeness does not represent approval for market, Caption Health points out in a news release, adding that Caption Guidance is currently undergoing FDA review.

The company, which is headed by former 23andMe president Andy Page, won the breakthrough designation after demonstrating the technology’s utility with eight registered nurses who had been novices with cardiac ultrasound.

After completing a short training program, the nurses obtained heart images deemed proper by a panel of experienced cardiologists.

“This is a landmark study of a breakthrough application of artificial intelligence in healthcare, and the top-line results are very promising,” says principal investigator Akhil Narang, MD, a cardiologist with Northwestern Medicine and the Feinberg School of Medicine.

Narang adds that the technology “offers the potential to empower more healthcare providers to perform ultrasound, including nurses, who are often the first point of care for patients.”