KinetiCor, Inc., secured FDA clearance for system used on Siemens Healthineers MRI Scanner.
KinetiCor, Inc., the only approved manufacturer of optical motion detection solutions for MRI scanners, received 510(k) clearance from the U.S. Food and Drug Administration Wednesday for its Motion Correction System.
This system is approved for use as an accessory to the Siemens Healthineers MAGNETOM Skyra 3T MRI scanner, and it uses sensor-based technology to track patient movement during an MRI scan. According to a company release, it provides the current patient position in real-time to the MRI scanner, allowing for further data processing. The system adjusts images as needed, offering head-pose tracking and correction within six degree of freedom for MR applications.
“During a neurological MRI, it’s difficult for a patient’s head to remain perfectly still, often leading to discomfort for the patient and, likewise, often rendering the resulting images to be unclear and lacking sharpness,” said Doug Donzelli, KinetiCor chief executive officer. “MRI degradation can prevent physicians from effectively analyzing MRI images and can frequently require that additional scans be performed.”
To counteract this issue in the Skyra 3T MRI scanner, he said, KinetiCor’s image correction software can identify inadvertent movement during the scanning process. The goal is to potentially reduce repeated MRI scans, saving hospitals, physicians, and insurers money each year.
This FDA approval is part of an ongoing innovation partnership with Siemens Healthineers, said KinetiCor’s chairman and chief technology officer Jeffrey Yu, M.D.