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Mara Geller

Aidoc to market an AI algorithm under the FDA’s enforcement policy for imaging systems

Aidoc – a leading provider of AI solutions for radiologists – announced today that its AI algorithm intended for adjunctive use in the detection of findings associated with COVID-19 will be marketed under the FDA’s Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The product is not cleared or approved.

The product detects and prioritizes incidental CT findings that may be associated with COVID-19 (e.g. ground-glass opacities (GGO) – a non-specific imaging finding associated with COVID-19 infection) in CT studies that contain the lung or part of the lung. Prioritization of these incidental findings may help manage patients with COVID-19 by providing adjunctive information that can facilitate prompt patient evaluation.

“In our experience, it is not unusual for the radiologist to be the first to suggest COVID-19 disease as a possible diagnosis. The outbreak of the COVID-19 pandemic may occur in waves and should these waves occur, it will become increasingly important to identify imaging findings suggestive of COVID-19 in a variety of clinical settings” said Dr. Paul Chang, Vice-Chair, Radiology Informatics at the University of Chicago Medicine. “Aidoc’s ability to detect incidental findings associated with COVID-19 acts as another layer of protection as the disease may continue to circulate in the months to come.”

In studies published by universities of Brussels, Chicago and Brescia, as well as a report from Maimonides Medical Center in New York, 8-10% of patients undergoing CT scans for other conditions were discovered by radiologists to have findings suggestive of COVID-19. These patients, who were undergoing oncology screenings or being screened for abdominal pain, did not exhibit any COVID-associated respiratory symptoms. Prompt identification of these incidental findings allows action to be taken sooner with regard to treatment or appropriate isolation. 

Apart from its COVID-19 products marketed under enforcement discretion,  Aidoc features a suite of AI radiology solutions with FDA and CE clearances that flag critical conditions including intracranial hemorrhage, large-vessel occlusion, PE in pulmonary angiography and cervical spine fractures. 

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