FDA Clears Upgrade of 3T MRI System for the Operating Suite

The Food and Drug Administration (FDA) has granted 510(k) clearance for the InVision 3T Recharge Operating Suite, an intraoperative magnetic resonance imaging (MRI) platform specifically designed for neurosurgical procedures. The InVision 3T Recharge Operating Suite features Magnetom Skyra Fit technology from Siemens Healthineers, according to Imris Imaging, the developer of the InVision 3T Recharge Operating Suite. Imris Imaging said key attributes of the ceiling-mounted system include artificial intelligence (AI)-enabled imaging protocols and automated post-processing image reconstruction. The company said the InVision 3T Recharge Operating Suite’s capabilities to streamline workflows and reduce scan times represent a “significant upgrade” for current users of the Imris Operating Suites with Siemens Healthineers’ Magnetom Verio magnets. “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,” noted Marc Buntaine, the CEO of Imris Imaging.