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Home » Medtronic wins FDA clearance for nerve monitoring system, acquires Ai Biomed

Medtronic wins FDA clearance for nerve monitoring system, acquires Ai Biomed

October 29, 2020 By Sean Whooley

Medtronic logo updatedMedtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its NIM Vital, and it’s acquired Ai Biomed.

NIM Vital is an intraoperative nerve monitoring system designed to allow physicians to identify, confirm and monitor nerve function in an effort to reduce the risk of nerve damage during head and neck surgery, according to a news release.

Fridley, Minn.-based Medtronic’s system uses proprietary technology to provide detailed intraoperative nerve condition data to inform surgical strategy, increase efficiency and precision and protect the patients’ quality of life. The NIM Vital system is CE Mark approved and available in Europe, too.

Additionally, the acquisition of Ai Biomed for an undisclosed amount adds the company’s PTeye parathyroid detection system to Medtronic’s ENT portfolio.

“Protecting critical structures during surgery has evolved to an extensive system that brings crucial information to the surgeon’s hands and eyes,” Harvard Medical School professor of otolaryngology Dr. Gregory Randolph said in the release. “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.”

PTeye is touted as the only probe-based technology of its kind, designed to help confirm parathyroid tissue identified visually by the physician during thyroid surgery, which Medtronic said is a crucial step during such a procedure.

The acquisition marks the seventh in a series of tuck-in acquisitions made by Medtronic during 2020. The company expects revenue and earnings contribution from this acquisition to be immaterial to its ENT business in the first year, but accretive thereafter, plus there is an expectation that the buy will meet the medtech giant’s long-term financial metrics for acquisitions.

Santa Barbara, Calif.-based Ai Biomed’s employees joined Medtronic’s ENT business as part of the acquisition, as well.

“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,” Medtronic VP & GM of its ENT business Vince Racano said. “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.”

Filed Under: 510(k), Business/Financial News, Featured, Food & Drug Administration (FDA), Mergers & Acquisitions, Neurological, Optical/Ophthalmic, Otolaryngology/Ear, Nose & Throat (ENT), Patient Monitoring, Regulatory/Compliance, Surgical Tagged With: aibiomed, Medtronic

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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