FDA Clears 5T Whole-Body MRI System

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.

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.