In a first, the FDA has cleared a powerful 7-tesla MRI scanner for clinical use.
The machine getting the go-ahead, limited to exams of the head and extremities, is Siemens Healthineers’ Magnetom Terra.
In an Oct. 12 announcement, the agency says it gave the scanner the thumbs-up after reviewing the safety of its radiofrequency subsystem through simulations and computational modeling as well as experimental validation.
Further, Siemens supplied data from a study that compared the 7T machine’s images of 35 healthy patients against images of the same anatomic structures acquired with a predicate 3T device on the market.
“Board-certified radiologists reviewed the images and confirmed that the images acquired on the 7T device were of diagnostic quality and, in some cases, an improvement over imaging at the 3T,” the agency states.
Robert Ochs, PhD, of FDA’s Center for Devices and Radiological Health, adds that the more-than-doubled static magnetic field strength of 7T over 3T “allows for better visualization of smaller structures and subtle pathologies that may improve disease diagnosis.”
In a press release, Siemens says the scanner has a dual-mode feature that allows the operator to switch between a research mode and the newly 510(k)-cleared clinical mode while safely storing research data and clinical images on separate databases.