IMRIS Imaging, Inc. Receives FDA Clearance for the InVision™ 3T Recharge Operating Suite

IMRIS has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the new InVision 3T Recharge Operating Suite

CHASKA, MN, UNITED STATES, August 13, 2025 /EINPresswire.com/ -- IMRIS Imaging, Inc., the global leader in intraoperative imaging, announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the new InVision 3T Recharge Operating Suite, a ceiling-mounted intraoperative MRI system specifically designed for diagnostic and intraoperative imaging. The InVision 3T Recharge provides an upgrade path for IMRIS Operating Suites currently utilizing Siemens’ MAGNETOM Verio magnets, enabling them with the new advanced capabilities of Siemens’ MAGNETOM Skyra Fit upgrade. The upgrade platform enables IMRIS customers to take advantage of the latest Siemens MRI technology including improved diagnostic imaging quality. Workflows are streamlined through AI powered imaging protocols and with automatic image reconstruction post processing managed as a background activity, enabling increases in productivity while reducing scan times.

“We’re delighted to be able to offer our IMRIS customers currently using the Siemens Verio platform this significant upgrade to their InVision System,” said IMRIS CEO Marc Buntaine. “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 MRI value to be enhanced at these clinical centers.”

IMRIS custom designs innovative intraoperative MRI systems specifically for imaging during neurosurgical procedures. An IMRIS InVision Operating Suite helps deliver timely information to clinicians, providing real-time visualization to assist in decision-making and enhance precision in treatment.

About IMRIS Imaging, Inc.
As a leader in image guidance solutions, IMRIS Imaging, Inc., provides optimized, fully integrated image-guided therapy environments that address the important needs of patients, clinicians, and hospitals by delivering timely MRI and imaging data to clinicians for use during surgical or interventional procedures. The IMRIS Operating Suite enables intraoperative imaging directly within operating rooms. The Company also designs and manufactures proprietary head fixation devices, imaging coils and OR tables for use in this unique and multifunctional intraoperative environment. IMRIS products are sold globally to clinical centers in the neurosurgical, spinal, cardiovascular and orthopedic markets. It is estimated that over 70,000 patients have benefited from lifesaving or life-extending procedures performed in an IMRIS Operating Suite. Additional information about IMRIS is available at www.imris.com.

Chelsey Wentz
IMRIS Imaging, Inc.
cwentz@imris.com
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