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Medical Devices / Submissions and Approvals

FDA Approves Marketing AI Technology to Help Diagnose Wrist Fractures

May 29, 2018

The FDA signed off on the marketing of an artificial intelligence program for easier detection of wrist fractures.

Imagen’s OsteoDetect uses an AI algorithm to analyze wrist X-rays in a variety of environments. “It is an adjunct tool and is not intended to replace a clinician’s review of the radiograph or his or her clinical judgment,” the FDA said in announcing its approval.

Imagen submitted two retrospective studies that the company claimed showed the technology could help practitioners better identify fractures.

The FDA reviewed OsteoDetect through the De Novo premarket review pathway for low-to-moderate-risk devices.

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