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AI-Based Screening Tool For Musculoskeletal Issues Gets US FDA Warning Letter

 
• By Elizabeth Orr

Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.

A physician looks over two screens with diagnostic images like a skeleton and MRI scan.
• Source: Shutterstock

The developers of an artificial intelligence-based diagnostic tool for musculoskeletal and neurological disorders need to change its marketing or stop distributing the product until it is approved under a PMA, a 10 February warning letter posted to the US Food and Drug Administration’s website this week states.

The Exer Scan from Denver-based Exer Labs Inc. is a mobile app that gathers real-time motion data to help clinicians monitor patients with musculoskeletal (MSK) concerns. The FDA cleared the...

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