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October 30, 2020

Medtronic receives FDA approval for NIM Vital nerve monitoring system

Medtronic has secured Food and Drug Administration (FDA) 510(k) clearance of the NIM Vital nerve monitoring system, which enables doctors to identify, confirm, and monitor nerve function to help cut down the risk of nerve damage during head and neck surgery.

Medtronic has secured Food and Drug Administration (FDA) 510(k) clearance of the NIM Vital nerve monitoring system, which enables doctors to identify, confirm, and monitor nerve function to help cut down the risk of nerve damage during head and neck surgery.

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The monitoring system uses proprietary technology to offer detailed intraoperative nerve condition data, which helps in devising a surgical strategy and boosting operative efficiency and preciseness.

The NIM Vital system enables physicians to find and identify nerves, monitor and control manipulation effects, and confirm nerve integrity before completing the surgery.

Due to a large touch-screen and streamlined interface, an intuitive, guided workflow with enhanced visualisation is possible.

The NIM Vital system is available in the US and it is also CE marked for distribution beyond the US.

Meanwhile, Medtronic has expanded its ear, nose, and throat (ENT) portfolio with the recent acquisition of privately held Ai Biomed Corp, manufacturer of the PTeye parathyroid detection system.

Considered to be the only probe-based technology of its type, the PTeye system is intended to help physicians confirm parathyroid tissue identified visually during thyroid surgery.

Medtronic vice-president and general manager of the ENT business, which is part of the Restorative Therapies Group, Vince Racano said: “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.

“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.”

The Ai Biomed acquisition is the seventh in a series of tuck-in acquisitions by the company during this year.

The revenue and earnings contribution is expected to be immaterial to the Medtronic ENT business in the first year and accretive thereafter.

In addition, the transaction is expected to meet Medtronic’s long-term financial goals for acquisitions. Additional terms of the agreement have not been disclosed.

The Ai Biomed Corp facility is based in Santa Barbara, California, US, and its employees joined Medtronic ENT as part of the acquisition.

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  • A proprietary algorithm that leverages numerous pricing sources, with an emphasis on real-world data
  • Estimates of the likely spread of selling prices per brand and manufacturer, as well as 3-year forecasts for prices
  • Medical device pricing data that can be tracked by market, company, and brand
  • Additional categories that can be built on a custom basis
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