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Medical Devices / Submissions and Approvals

China Gives Innovative Device Designation to Cancer Treatment

Aug. 13, 2019

Shanghai-based Zai Lab’s Optune, a tumor treating electric fields delivery device, has received China’s innovative medical device designation.

The device uses electric fields at certain frequencies to disrupt cancer cell division, inhibiting tumor growth and killing cells.

The designation puts Zai Lab’s Optune on a faster approval track, with an opportunity for feedback from China’s regulator along the road to approval.

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