Fierce 15 winner MaxQ AI, formerly known as MedyMatch, has received a 510(k) clearance from the FDA for its artificial intelligence software that rapidly detects brain bleeds in CT scans.
Its Accipio Ix detection platform had previously been granted access to the agency’s expedited access pathway, which allowed the Tel Aviv, Israel and Andover, Massachusetts-based company to receive FDA advice while it went through the review process.
The clearance now allows emergency healthcare providers and physicians in acute care settings to use the program to prioritize clinical assessment and care of patients with hemorrhagic stroke or intracranial trauma. Accipio Ix previously received a CE mark in May.
“MaxQ’s Accipio application, of which Accipio Ix is the first part of the ecosystem, provides physicians with actionable intelligence, improving their future ability to make a timely, accurate and more confident diagnosis of a brain bleed,” said Gene Saragnese, chairman and CEO of MaxQ AI.
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The Accipio line is designed to be integrated with most existing medical workflow platforms and imaging technologies, including CT, MRI and ultrasound, both locally and on cloud-based servers.
The company’s own diagnostic tool, Accipio Dx, received a breakthrough device designation from the FDA earlier this year.
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Last year, MaxQ announced AI partnerships with Samsung and IBM Watson to integrate its products into their radiology software and hardware platforms. The company also signed a five-year distribution deal with GE Healthcare in November 2017.
Samsung NeuroLogica plans to use the software in mobile stroke units equipped with its CereTom CT scanner. The companies hope it will allow staff to differentiate between ischemic strokes and hemorrhagic strokes in the field, and allow them to give drugs to dissolve the clots behind an ischemic stroke while en route to the hospital.
These partnerships will help simplify Accipio’s deployment and adoption, Saragnese said.