Aidoc granted AI ‘industry-first’ FDA clearance for triage of incidental pulmonary embolism

Smart radiology company Aidoc Medical Ltd. has announced it has been granted regulatory clearance from the U.S. Food and Drug Administration (FDA) for the sixth time. The clearance paves the way for the commercial use of its triaging and notification algorithms for flagging and communicating incidental pulmonary embolism.

The cleared solution provides an ‘always-on’ safety net for unexpected cases, now available alongside five other FDA-approved tools for triage and notification: Intracranial Hemorrhage, C-Spine Fractures, Large Vessel Occlusion, Intra Abdominal Free Gas, and Pulmonary Embolism on dedicated exams.

"There's a reason why most AI triage solutions don't focus on incidental findings," said Michael Braginsky, Aidoc's CTO. "Because the prevalence of incidental findings is relatively low, the specificity of the AI must be especially high, otherwise the false positive rate will be excessive and user adoption will be negatively impacted. In addition, an incidental PE algorithm detects PE in non-dedicated exams, where contrast is by definition suboptimal, and there’s an extremely high variability of protocols that challenge the AI even further. It was a scientific breakthrough that our team achieved that made this possible."

“The most common use case we experienced is for critical unsuspected findings in oncology surveillance patients” added Dr. Cindy Kallman, Chief, Section of CT at Cedars-Sinai Medical Center. “The ability to call the referring physician while the patient is still in the house is huge. We are essentially offering a point-of-care diagnosis of PE for our outpatients, with almost no extra effort. Our referring physicians have been completely wowed by this.”

Aidoc was founded in 2016 by Elad Walach, Guy Reiner, and Michael Braginsky. It provides artificial intelligence tools to assist radiologists by detecting and pinpointing abnormalities with deep learning and AI algorithms that analyze medical images. In September, it raised $20 million in series B bringing its total funding to $60 million.