October 29, 2020 – Medtronic plc (Dublin, Ireland) received U.S. Food and Drug Administration (FDA) 510(k) clearance of the NIM Vital nerve monitoring system, which enables physicians to identify, confirm, and monitor nerve function to help reduce the risk of nerve damage during head and neck surgery.
The NIM Vital system uses proprietary technology to provide detailed intraoperative nerve condition data that informs surgical strategy, increases operative efficiency and precision, and helps protect patients’ quality of life, Medtronic says.
The company also announced further enhancement of its ENT portfolio with the recent acquisition of privately-held Ai Biomed Corp., maker of the PTeye parathyroid detection system. The only probe-based technology of its kind, the PTeye system is designed to help confirm parathyroid tissue identified visually by the physician during thyroid surgery.
The NIM Vital system enables surgeons to locate and identify nerves, monitor and control manipulation effects, and confirm nerve integrity prior to completing the surgery. Proprietary technology provides real-time feedback on nerve function during intermittent or continuous monitoring so surgeons can adjust course as needed. A large touch-screen and streamlined interface provide an intuitive, guided workflow with enhanced visualization. Now available in the United States, the NIM Vital system is also CE marked for distribution outside the U.S.
The acquisition of Ai Biomed Corp. expands upon intraoperative technology like the NIM Vital platform and supports Medtronic’s goal of using innovative technologies to improve head and neck surgery. The acquisition of Ai Biomed Corp. is the seventh in a series of tuck-in acquisitions that Medtronic has made in calendar year 2020.
Additional terms of the agreement are not being disclosed. The Ai Biomed Corp. facility in Santa Barbara, California, and its employees joined Medtronic ENT as part of the acquisition.