In what represents its first patenting, Pittsburgh-based Reach Neuro Inc. is seeking protection for methods, sensors, and systems for detecting movement of a spine and stimulating specific regions of the spinal cord in response to the movement.
The U.S. FDA posted two warning letters to device makers in the second week of March 2024, one each to Exactech Inc., of Gainesville, Fla., and the other to Nobles Medical Technology II Inc., of Fountain Valley, Calif. The themes of these warnings are entirely different, with Noble receiving a warning regarding clinical trial oversight and Exactech taking a hit for routine good manufacturing compliance issues, showing that the FDA is active in the post-COVID compliance realm.
The U.S. FDA announced March 7 that Cardinal Health of Dublin, Ohio, has expanded a product correction for Monoject devices to a product removal because of manufacturing changes that could affect product performance.