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Clinical diagnostic and workflow software maker MaxQ AI has received FDA 510(k) marketing clearance for Accipio Ix, an artificial intelligence workflow tool designed to help clinicians prioritize adults patients likely presenting with acute intracranial hemorrhage. The company received notification from the FDA of its decision in late October.

Results generated by the algorithm-based software are not intended to be used on their own as a standalone diagnostic or for clinical decisions. Rather, the tool automatically retrieves and processes non-contrast CT images to provide a case-level indicator, which is used to triage cases most in need of expert review.

MaxQ AI noted in its clearance announcement that it will be demoing the technology later this month at the Radiological Society of North America’s annual meeting in Chicago.

What’s the impact

Like other approved AI tools, MaxQ AI’s software could help relieve specialists from high case loads and render speedy diagnoses for the patients in greatest need.

“Accipio Ix’s ability to greatly increase suspected bleed detection, improve escalation and time to review is a game-changer,” Gene Saragnese, CEO and chairman of MaxQ AI, said in a statement. “Further, our partnerships with top CT and PACS companies including GE Healthcare, Samsung Neurologica and other organizations prior announced, make deployment and adoption of Accipio straightforward. … The potential impact is massive — only one patient diverted from acute stroke to wellness in the 13,000 US/EU hospitals represent $2 billion savings in a single year, and a lifetime of difference to the patient and their families.”

Saragnese also noted that the tool is the first offering in the company’s plan for a wider MaxQ Accipio app ecosystem.

What’s the trend

Accipio Ix already won a CE Mark earlier this year, and has since been commercially available to European hospitals.

The 510(k) approval comes months after the FDA granted De Novo clearance to Viz.ai’s Contact, the clinical decision support tool upon which MaxQ AI based its application.

Regulation of clinical decision support tools has been developing an issue over the past year. In accordance with the 21st Century Cures Act, the agency released draft guidance late last year that outlined regulated devices based on the degree of human involvement, as opposed to doing so based on risk. Reactions from industry experts and analysts were mixed at the time, but comments submitted to the FDA months later by the CDS Coalition — a group that includes representatives from clinical societies, payers, providers, software developers, and other parties — has since framed the draft as a misstep.