RapidAI receives ‘groundbreaking’ FDA clearance for its neuroimaging stroke platform

Stroke imaging company RapidAI on Tuesday received Food and Drug Administration clearance for its machine learning-powered imaging device to improve stroke care.

The system, known as Aspects, is the first neuroimaging solution in the FDA’s computer-assisted diagnostic software category to receive this designation, the company said June 7. It’s named after the Alberta stroke program early CT scoring system, and combines such measurements with a physician’s image interpretation to boost stroke identification.

“Rapid Aspects represents the next AI-powered step forward in stroke imaging, and the groundbreaking CADx clearance from the FDA puts it in a class by itself,” said Co-founder of the company Greg Albers, MD, adding that the system is particularly useful for less experienced radiologists

According to Menlo Park, California-based RapidAI, its platform automatically produces an Aspect score in a “few minutes” helping doctors pinpoint brain regions with irreversible injury and a patient’s eligibility for thrombectomy. Rapid says the solution will allow for quicker triage and transfer decisions for improved outcomes.

The neuroimaging offering is part of Rapid’s overall stroke imaging suite, which was built using more than 650,000 scans from hospitals across the world. Rapid Aspects will be commercially available in the U.S. later this month, the company said.

“Through a combination of clinically validated advances in AI and machine learning, Rapid Aspects offers a glimpse into the future of stroke imaging,” said Jim Rosa, senior vice president of regulatory and clinical matters at RapidAI.