Minnetonka, Minn.-based IMRIS received clearance from the U.S. Food and Drug Administration for the next generation of its VISIUS Surgical Theatre, an intraoperative imaging system.
VISIUS Surgical Theatre is a transportable magnetic resonance and computed tomography imaging system. Surgeons can request the system be brought to the operating room if necessary during a procedure, eliminating the need to move the patient for imaging and reducing the risk of patient harm, according to IMRIS' website.
This latest generation that received FDA clearance integrates Munich, Bavaria-based Siemens' latest MR scanners and will "deliver better image quality with higher signal-to-noise ratio, faster 3D image acquisition and improved ease of use and workflow during neurosurgical procedures using intraoperative MRI," according to the news release.
More Articles on FDA Cleared Devices:
FDA Clears Given Imaging's PillCam COLON for Incomplete Colonoscopies
Sofosbuvir Earns FDA Approval as Hepatitis C Treatment
FDA Approves Medtronic's CoreValve Transcatheter Without Panel Review