IMRIS Imaging Inc. has received 510(k) clearance from the FDA for its InVision 3T Recharge Operating Suite, a ceiling-mounted intraoperative MR system designed to support both diagnostic and surgical imaging workflows.

The newly cleared system enables clinical centers currently using Siemens’ MAGNETOM Verio platforms to upgrade to the MAGNETOM Skyra Fit, part of Siemens’ Biomatrix line. The Skyra Fit platform offers updated MR technology that integrates AI-powered imaging protocols and automatic image post-processing, which the company says may reduce scan times and streamline intraoperative workflows.

“The InVision 3T Recharge brings the latest state-of-the-art Siemens Skyra Fit Biomatrix technology to an IMRIS Operating Suite, extending the life of the initial investment and enabling IMRIS intraoperative MR value to be enhanced at these clinical centers,” said Marc Buntaine, CEO of IMRIS Imaging Inc.
The Chaska, Minnesota-based company specializes in custom-built intraoperative MR suites tailored for neurosurgical procedures. These suites enable real-time imaging during surgery, aiming to assist with intraoperative decision-making and potentially improving surgical outcomes.

The new suite is positioned as a retrofit option for existing IMRIS installations, offering a pathway to maintain and modernize systems without full replacement. Along with MR integration, IMRIS provides proprietary components for these operating rooms, including OR tables, imaging coils and head fixation devices.

IMRIS reports that its technology has been used in procedures for more than 70,000 patients worldwide, across neurosurgical, spinal, cardiovascular and orthopedic specialties.

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