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Legal, Clinical & Regulatory

Brainlab Recalls Spine & Trauma 3D Navigation Software

The recalled software is used with Brainlab's navigation system during spinal and trauma procedures, providing patient images to navigate surgical tools and implants used before and during minimally invasive procedures. FDA has identified this as a Class I recall.   

FDA 510(k) Recap: A Spinal Cage from a Biologics Company, a Trauma Device from a Spine Company; Additive, Surgical Platforms

Orthopedic companies large, mid-sized and small are gaining FDA clearance for products in new materials, and made with attractive manufacturing methods like 3D printing. Companies like Kuros Biomedical and Nvision are making strategic decisions to move into adjacent markets, and additive manufacturing continues to be a part of the picture. 

FDA Proposes Framework for Artificial Intelligence-Based Devices

Artificial intelligence technology is evolving quickly, and the potential benefits of adaptive AI systems in relation to modern medicine are seemingly endless. FDA plans to establish a new regulatory framework for medical devices that use advanced AI algorithms.