SpinTech Gets FDA 510(k) Clearance for MRI Software
Bingham Farms, Mich.-based SpinTech has received 510(k) clearance from the FDA for its STAGE (strategically acquired gradient echo) magnetic resonance imaging (MRI) software.
The STAGE system, which can scan the brain in roughly five minutes, provides 16 different image contrasts and six types of quantitative data to show changes in a patient's condition between an initial scan and subsequent examinations.
The STAGE platform is designed to improve the diagnosis and treatment of various neurological conditions. SpinTech claims it is 40 percent faster than other scanning methods in acquiring and processing MRIs, allowing more patients to be scanned each day.