Manus’ NeuroMotor Pen for Parkinson’s Diagnosis Designated a Breakthrough Device

Manus Neurodynamica has been granted the FDA’s Breakthrough Device designation for its NeuroMotor Pen, intended to help diagnose Parkinson’s disease.

The device’s proposed indication is to help healthcare providers differentiate between Parkinsonian and nonParkinsonian tremors in adult patients who are believed to have Parkinson’s disease but have not been diagnosed by other means.

The pen combines a sensor and analytical software to record minute limb and hand motions, quantifying fine motor skill. The quantified parameters are used as “digital biomarkers” to accurately identify tremor disorders, the company said.