FDA approves new AI software for brain bleed diagnosis

MaxQ AI’s Accipio Ix intracranial hemorrhage (ICH) detection software has gained FDA clearance, the company announced this week. The software helps providers assess non-contrast head CT examinations for signs of ICH, also known as brain bleed.

Gene Saragnese, chairman and CEO of MaxQ AI, said in a prepared statement that this software is the first of many that will make up the company’s Accipio ecosystem of products. It has already gained CE Mark approval.

The software was designed to use AI technology without storing the patient’s protected health information or altering the original CT images in any way. Patients showing signs of ICH are identified and prioritized.

“The potential impact is massive—only one patient diverted from acute stroke to wellness in the 13,000 U.S./E.U. hospitals represent $2 billion savings in a single year, and a lifetime of difference to the patient and their families,” Saragnese said in the same statement.