IMRIS Gets FDA OK for HFD Rocker Arm
IMRIS has launched its HFD rocker arm for use in stabilizing patient’s heads during neurological procedures that use intraoperative imaging, following receipt of FDA 510(k) clearance on Sept. 4. The device is intended for use with the company’s VISIUS surgical theatre.
VISIUS uses high-field intraoperative magnetic resonance imaging to give surgeons access to real-time diagnostic depictions of brain tissue, according to the Minneapolis, Minn., devicemaker. The scanner moves on ceiling-mounted rails to the desired position over the patient.
The rocker arm attaches to VISIUS’ clamp-like head fixation device, reducing pressure on the patient’s skull. The arm also allows the surgeon to stabilize, support and position heads with varying cranial anatomy, size and conditions, IMRIS said. — Kellen Owings
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