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.