Radiology startup Aidoc received its sixth FDA clearance — and an important first for the company. The Tel Aviv-based startup got the green light to use its AI triage solution to detect incidental pulmonary embolism in CT scans — flagging cases that physicians didn’t originally suspect.
Pulmonary embolism (PE) occurs when a blood clot gets lodged in one of the lung’s arteries. Prompt diagnosis and treatment is critical.
Aidoc already had a cleared solution to detect pulmonary embolism, but that was for dedicated exams where patients received CT scans specific to that condition.
Flagging incidental findings is a much trickier technical problem because there are fewer unsuspected cases, and too many false positives could render the tool useless.
“There’s a reason why most AI triage solutions don’t focus on incidental findings,” Aidoc CTO Michael Braginsky said in a news release. “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.”
The tool would flag incidental findings for further review by a radiologist.
Los Angeles-based Cedars-Sinai Medical Center implemented Aidoc’s original pulmonary embolism product into its workflow. Most commonly, they discover unsuspected PE cases in oncology patients during their cancer surveillance, according to Cedars-Sinai’s chief of CT, Dr. Cindy Kallman.
“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,” Kallman said in a news release.
Aidoc’s other cleared triage tools are for intracranial hemorrhage, c-spine fractures, large vessel occlusion and intra-abdominal free gas. The company also received an emergency use authorization from the FDA to flag incidental Covid-19 cases from CT scans.
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