VCBeat (WeChat: vcbeat) learned from foreign media that on November 7, 2018, U.S. local time, MaxQ AI (hereinafter referred to as “MaxQ”), a manufacturer of clinical diagnostic and workflow software, announced that its AI product, Accipio Ix, had received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA). Accipio Ix is an artificial intelligence–powered workflow software designed to help clinicians prioritize treatment for adult patients with suspected acute intracranial hemorrhage. The FDA’s review decision on this product was released in late October of this year.

Image source: MaxQ official website
Earlier this year, MaxQ announced that it had obtained the European CE mark and approval for commercialization in the European Union. Now, Accipio Ix has successfully entered the U.S. market.
Accipio Ix helps physicians alleviate the workload associated with managing a high volume of cases simultaneously, enabling rapid diagnosis for patients in greatest need. As the first product in MaxQ’s Accipio INSIGHT application ecosystem, Accipio Ix leverages artificial intelligence to maintain high sensitivity for intracranial hemorrhage (ICH), assisting physicians in identifying ICH patients and establishing treatment priorities.
Accipio Ix leverages artificial intelligence to automatically analyze patients’ non-contrast head CT images without disrupting user workflows, altering original sequences, or storing protected health information (PHI). It not only assists physicians in prioritizing patient care but also integrates relevant information into CT (Computed Tomography) and PACS (Picture Archiving and Communication System) systems via DICOM (Digital Imaging and Communications in Medicine). Accipio Ix is available both as a downloadable installation and as a cloud-based solution.
It is well known that AI tools can help clinicians prioritize patients requiring immediate diagnosis and treatment, but they do not make decisions independently.
Gene Saragnese, Chairman and CEO of MaxQ, stated, “Accipio Ix significantly enhances the detection of suspicious hemorrhages, facilitating patient triage and reducing review time. This is a game-changing approach. Furthermore, our partnerships with leading CT and PACS companies, including GE Healthcare and Samsung Neurologica, have simplified the deployment and promotion of Accipio.”
This technology is projected to save $2 billion annually for 13,000 hospitals across the United States and the European Union. Gene Saragnese added, “Even if just one patient regains health after an acute stroke, it will mean a completely different life for that patient and their family.”
MaxQ stated that it will showcase its Accipio Ix product and the full suite of Accipio platform solutions later this month during the Radiological Society of North America (RSNA) annual meeting in Chicago.
About MaxQ AI
MaxQ, founded in 2013 with dual headquarters in Massachusetts, USA, and Tel Aviv, Israel, aims to provide AI-powered decision support to healthcare institutions and professionals to improve clinical outcomes in acute care settings. The company has currently reached Series A financing, having raised a total of approximately $9 million across three funding rounds, with Exigent Capital as its primary investor.