Plans were released earlier this month detailing a new regulatory framework for devices that employ advanced artificial intelligence. The discussion paper includes questions for feedback on requirements for premarket review applications and the role that real-world evidence plays in supporting transparency.
Long industry lead times have been a point of contention in the past year, as many wait months for products to be manufactured. Dale Tempco, a specialist in product development, shares his expertise on the unique orthopedic model, the introduction of new products and supply chain impact.
The company now has FDA 510(k) clearance for knee, spine and brain offerings on one robotic platform. ROSA ONE features 3D intraoperative planning software and navigation to support implant and instrument placement accuracy and predictability.
MiRus received FDA 510(k) clearance for Europa, a pedicle screw made with proprietary MoRe molybdenum rhenium superalloy. MoRe's use may help address issues such as rod failure in spinal deformity procedures, and could enable the creation of lower-profile foot and ankle implants.
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