KinetiCor Wins FDA 510(k) Clearance for Motion Correction System for Siemens MAGNETOM Skyra 3T Scanner
by KinetiCor on 02/19/2020
Patented Optical Sensor-Based Technology Works Within MRI System to Track and Correct Patient Movement During Scans
San Diego, CA – February 19, 2020 – KinetiCor, Inc., today’s only FDA 510(k) cleared optical motion detection solution for advanced Magnetic Resonance Imaging (MRI) scanners, today announced that the KinetiCor Motion Correction System has received FDA 510(k) clearance for the Siemens MAGNETOM Skyra 3T MRI scanner. The patented KinetiCor system is an accessory to the Skyra scanner, and uniquely leverages sensor-based technology for tracking of patient movement during an MRI session. It helps provide the current position of the patient in real-time to the MRI scanner for further data processing. It is intended to support, supplement and/or augment the performance of the MAGNETOM Skyra 3T MRI scanner.
“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, CEO of KinetiCor. “MRI degradation can prevent physicians from effectively analyzing MRI images and can frequently require that additional scans be performed. Our patented image correction technology promises to bring unprecedented accuracy to images coming from the Skyra T3 MRI scanner because it can identify inadvertent movement during the scanning process. Our hope is that our technology will dramatically reduce repeat MRI scans, and potentially save hospitals, physicians and insurers millions annually.”
The KinetiCor Motion Correction system is optimized for high field MR environments and uses an optical tracking sensor array to monitor the true position of a patient’s head. Its proprietary optical machine vision motion tracking technology delivers tracking data to the MRI scanner in real-time. The scanner then adjusts the MR images as indicated. The KinetiCor Motion Correction System provides “head pose” tracking and correction within six degrees of freedom for MR applications.
“FDA clearance of our solution for a widely available scanner is a major milestone in our progress toward providing more accurate, efficient and cost-effective MRI operations for hospitals, physicians, patients and insurers around the world. We are pleased with the 510(k) clearance we have received from the FDA, and look forward to continuing our innovation with Siemens and other MRI providers globally,” Added Jeffrey Yu, M.D., KinetiCor’s Chairman and CTO.
KinetiCor, founded in 2009, is a medical system company dedicated to improving the quality of medical imaging via its patented prospective motion correction technology. The KinetiCor platform is currently FDA 510(k) cleared for patient monitoring and motion detection with certain Siemens MAGNETOM MRI systems and sequences, and is in investigational use with a broader array of MRI systems and sequences. The KinetiCor platform has the potential to increase the efficiency of MRI scans and reduce the frequency of poor-quality scans due to movement. With KinetiCor, the medical imaging experience is improved for patients, physicians, providers and insurers and holds the promise of improved outcomes and cost savings. To learn more about KinetiCor, and its solutions, visit www.kineticor.com.
 FDA 510(k) clearance references use in only Siemens Healthineers MAGNETOM Sola 1.5T, Skyra 3T, and Vida 3T scanners