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IMRIS obtains FDA 510(k) approval for HFD rocker arm

IMRIS has secured 510(k) approval from the US Food and Drug Administration for its head fixation device (HFD) rocker arm.

rocker

The new rocker arm accessory helps surgeons to stabilize, support and position patient heads with varying cranial anatomy, sizes and conditions using the MRI-compatible IMRIS HFD.

The rocker arm decreases the pressure on the individual contact points on the patient’s skull, when attached to the HFD, said IMRIS.

IMRIS President and CEO Jay Miller said that providing optimal tools for neurosurgeons will allow more patients to benefit from the value of diagnostic quality imaging in the operating room with VISIUS iMR.

"The development of the rocker arm is an example of IMRIS’ ability to design products and features that allow neurosurgeons to use intraoperative MR inside the VISIUS Surgical Theatre for an expanding patient population," Miller added.

IMRIS, through its VISIUS Surgical Theatre, provides image guided therapy solutions. The theatre serves neurosurgical, spinal, cardiovascular and cerebrovascular markets.

Image: The IMRIS neurosurgical MRI-compatible head fixation device now has a rocker arm accessory to expand patient population. Photo: courtesy of CNW Group/IMRIS Inc.