Today (Wednesday), Israeli MedTech startup Aidoc, which develops AI-powered diagnostic tools for radiologists, announced that the US Food and Drug Administration (FDA) has given regulatory clearance for its triaging and notification algorithms for flagging and communicating incidental pulmonary embolism. This marks the company’s sixth FDA clearance for AI diagnostic tools.
Aidoc’s AI-algorithms help flag incidental critical findings, which is a huge technical challenge due to the varied imaging protocols and minimal cases available. The ability to prioritize incidental critical conditions accurately is a breakthrough in the value AI can bring to the radiologist workflow.
“The most common use case we experienced is for critical unsuspected findings in oncology surveillance patients,” said 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.”
The Israeli startup’s recently FDA cleared clinical solution provides an always-on safety net for unexpected cases and will be available alongside Aidoc’s five existing FDA cleared tools for the triage and notification of 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 challenges the AI even further. It was a scientific breakthrough that our team achieved that made this possible."
The company which was founded by 3 graduates of the Israeli military’s elite science unit, Talpiot. CEO Elad Walach, CTO Michael Braginsky, and VP of R&D Guy Reiner. A little more than a month ago, Aidoc completed its Series B funding round with $20 million in funding, bringing the total round to $47 million raised.