FDA Clears 5T Whole-Body MRI System
In addition to enhanced resolution, the uMR Jupiter 5T device reportedly addresses image uniformity and radiofrequency safety that have been previous challenges with ultra-high-field MRI.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the uMR Jupiter 5T system, the first ultra-high-field magnetic resonance imaging (MRI) system to gain clearance for full-body exams.
Equipped with an eight-channel whole-body multi-transmit system, the uMR Jupiter 5T system bolsters the clarity and detail of anatomical structures, according to United Imaging, the manufacturer of the device. The company said the 5T MRI system offers enhanced imaging capabilities for the heart, abdomen and pelvis that will facilitate improved diagnostic precision.
Reportedly the first ultra-high-field magnetic resonance imaging (MRI) system to gain FDA clearance for full-body exams, the uMR Jupiter 5T system offers enhanced imaging capabilities for the heart, abdomen and pelvis that may facilitate improved diagnostic precision. (Image courtesy of United Imaging.)
In addition to improved visualization of challenging anatomical regions, United Imaging noted that the device’s design and technology address previous issues associated with ultra-high-field MRI by ensuring radiofrequency safety and consistent imaging quality.
“We have always prioritized innovation that can make a broad clinical impact. Because it is aimed first and foremost at bringing ultra-high-field into greater clinical use, we believe (the uMR Jupiter 5T system) will have an exciting impact across our industry, and for clinical patients across the globe who have never had access to ultra-high-field in the past,” noted Jeffrey M. Bundy, Ph.D., the president and chief commercial officer of United Imaging in North America.
Meta-Analysis Shows No Difference Between bpMRI and mpMRI in Ruling Out csPCa
March 6th 2025In an 18-study meta-analysis involving over 4,600 patients, researchers found that bpMRI and mpMRI had equivalent pooled negative predictive value (NPV) of 92 percent for clinically significant prostate cancer (csPCa).
Is MRI Contrast Enhancement Necessary for Long-Term Monitoring of Diffuse Glioma?
March 4th 2025In a comparison of contrast-enhanced T1-weighted (CET1w) MRI (and T2-weighted MRI/FLAIR imaging, researchers found that only three out of 82 cases of glioma progression were solely detected with CET1w MRI.
Can Deep Learning Ultra-Fast bpMRI Have an Impact in Prostate Cancer Imaging?
March 3rd 2025A deep learning-enhanced ultra-fast bpMRI protocol offered similar sensitivity for csPCa as mpMRI with an 80 percent reduction in scan time, according to research findings presented at the European Congress of Radiology (ECR) conference.
