Medtronic buys Ai Biomed; earns FDA nod for NIM vital nerve monitor

Medtronic plc has 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.

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,5 the PTeye system is designed to help confirm parathyroid tissue identified visually by the physician during thyroid surgery.

“Protecting critical structures during surgery has evolved to an extensive system that brings crucial information to the surgeon’s hands and eyes,” said Gregory Randolph, M.D., professor of Otolaryngology, Claire and John Bertucci endowed chair in Thyroid Surgical Oncology at Harvard Medical School and surgeon at Massachusetts Eye and Ear Infirmary. “There are things we can’t do with our eyes and our hands. Both the NIM Vital and PTeye systems empower surgeons to improve their procedures, and Medtronic continues to provide these types of important operative solutions.”

“The addition of these two technologies builds on our 20-year legacy of providing innovative solutions that assist surgeons during critical head and neck procedures,” said Vince Racano, vice president and general manager of the ENT business, which is part of the Restorative Therapies Group at Medtronic. “By offering these complementary technologies—the NIM Vital system to protect crucial nerves and the PTeye system to help confirm parathyroid tissue identified visually by the surgeon—we’re helping physicians address two of the most common challenges during these procedures.” MPO