Company: Zimmer Biomet Date of Enforcement Report: 10/29/2021 Class I PRODUCT ROSA One 3.1 Brain Application: The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report: 10/29/2021 Class I PRODUCT ROSA One 3.1 Brain Application: The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different...Read More

“From my 25 years at the agency, I completely understand that FDA CDRH guidance development, approval and publication is complex, time-consuming work. I often said it may be compared to threading 1000 needles simultaneously. It requires significant time and energy from many hard-working, dedicated professionals to even reach the first goal of published draft guidance....Read More