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Renishaw wins FDA approval for neurosurgery planning software

By Christopher Calnan | October 24, 2017

RenishawRenishaw, a British engineering company, received approval by federal officials to sell the latest version of its neurosurgery planning software in the U.S.

The FDA granted 510(k) clearance for Renishaw’s neuroinspire software that blends MRI and CT datasets into a 3D volume, enabling neurosurgeons to identify and outline regions of interest. The approach is designed to minimize the chance of hitting key anatomy during the procedure.

The neuroinspire software can be used to plan a range of procedures and assist neurosurgeons to target anatomy concealed deep within the brain tissue.
Renishaw, founded in 1973, developed a line of Neuromate robots for neurosurgical procedures.The company employs about 4,000 workers.
Neurosurgeons using neuroinspire can create plans based on procedure type with tools tailored to the procedure. Users can choose to work on a deep brain stimulation  to reduce the symptoms of Parkinson’s disease, a stereoelectroencephalography to identify the area of the brain responsible for epileptic seizures or a biopsy to assist with the diagnosis of a brain tumor.

The latest version of neuroinspire software supports more data formats than previous versions and features semi-automatic profiling that enables surgeons to identify anatomical features.

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