FDA ok’s SpinTech’s STAGE platform for rapid brain imaging

PARCA eNews – The US Food and Drug Administration (FDA) has given 510(k) clearance to SpinTechMRI’s latest magnetic resonance imaging software device, STAGE (STrategically Acquired Gradient Echo), a post-processing software platform.

The software enables comprehensive, quantitative brain imaging with enhanced visualization in significantly less time than conventional MRI. STAGE allows MRI techs to acquire 16 brain imaging contrasts, including 10 enhanced contrast qualitative outputs and 6 quantitative outputs in just 5 minutes, according to a SpinTechMRI press release.
“STAGE’s FDA clearance is a huge breakthrough for SpinTech MRI,” said Ward Detwiler, SpinTech MRI’s CEO in the press release. “After years of developing and refining the platform through extensive research use, we are incredibly excited to make this game-changing technology available for clinical use in hospitals and imaging centers.”

The technology works with both 1.5T and 3T systems and can improve the efficacy of old and new MRI systems without taking machines offline or investing in expensive hardware upgrades.

The FDA approval allows a narrow indication use and does not extend to imaging outside of brain uses, and should always be used in combination with at least one other conventional MRI acquisition technique.

The software is currently used in over 50 hospitals, imaging centers and research facilities.

Source: SpinTechMRI press release