ClearPoint Neuro earns FDA approval for SmartFrame OR stereotactic system

Spinal Tech

ClearPoint Neuro earned FDA 510(k) clearance for its SmartFrame OR stereotactic system, according to a Jan. 16 news release. 

The SmartFrame OR stereotactic system is made of two parts — the SmartFrame OR and ClearPointer optical navigation wand, the release said. SmartFrame OR helps provide guidance for placement and operation of instruments and devices suring neurosurgical procedures.

A limited market release is planned for the first half of the year, and a full release is planned for the second half.

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