Aidoc Gains FDA Clearance for AI in Spinal Fracture Detection

By Julie A. Vetalice

Aidoc was granted FDA 510(k) clearance to market an artificial intelligence (AI) solution to triage fractures in the cervical spine. By prioritizing suspected fracture cases in a radiologist's worklist, the AI-powered triage automatically prioritizes critical cases to ensure that they are diagnosed in the most timely manner.

AI-powered triage can help counteract physician burnout related to "hunt and search" tasks and the documentation process, and can help manage the sheer volume of images that a physician is expected to analyze. For instance, radiologists are expected to interpret one image every three to four seconds just to keep up with workloads. The radiologist's workload in one day in 2018 is reportedly equivalent to one week in 2008 and one month in 1998.

Michael Braginsky, Aidoc co-founder and CTO, said, "The key for us was to create a scalable AI engine, a way to rapidly develop high-quality healthcare-grade algorithms. Our C-spine solution tested the limits of what we could do because of the difficulty in detecting spine fractures due to the variability by which they present."

The cervical spine application is also approved under the CE Mark. The system is also FDA cleared and CE Mark approved for detecting certain acute abnormalities in the head and chest.

Source: Aidoc Medical

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Tags: 510(k) Clearance, Regulatory