www.fdanews.com/articles/197991-rapidais-neuroimaging-analysis-device-cleared
RapidAI’s Neuroimaging Analysis Device Cleared
July 9, 2020
The FDA has cleared RapidAI’s Rapid Aspects neuroimaging analysis device for assessing brain injuries in stroke patients.
The device uses a machine-learning algorithm to identify early signs of brain infarctions. It is the first neuroimaging analysis device to receive the agency’s computer-assisted diagnostic software clearance.
The neuroimaging device helps stroke teams quickly assess patient eligibility for blood clot removal, enabling faster triage and better patient outcomes, the company said.