Aidoc granted AI industry-first FDA clearance for triage of incidental pulmonary embolism
This is the company's 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market
Oct 21, 2020, 09:00 ET
NEW YORK, Oct. 21, 2020 /PRNewswire/ -- Aidoc announced today that the US Food and Drug Administration (FDA) has given regulatory clearance for the commercial use of its triaging and notification algorithms for flagging and communicating incidental pulmonary embolism. Flagging incidental, critical findings is a huge technical challenge due to the varied imaging protocols used and lower incidences of such cases. 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. Our referring physicians have been completely wowed by this."
This recently cleared 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.
"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 which challenges the AI even further. It was a scientific breakthrough that our team achieved that made this possible."
Just last month the CMS approved the first reimbursement opportunity for AI – specifically for computer-assisted triage and notification of patients with suspicion of stroke. This is a very positive industry outcome and applies to Aidoc's AI solution for triaging and flagging Large Vessel Occlusions. Aidoc is working to submit other AI solutions to this reimbursement program.
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