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 BrusselsChicago 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 occlusionPE in pulmonary angiography and cervical spine fractures. 

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Mara Geller