MRI coil developer MR Instruments has received U.S. Food and Drug Administration (FDA) 510(k) clearance, the European CE Mark, and Health Canada approval for its 1.5-tesla DuoFlex coil suite.
DuoFlex, which operates on 1.5-tesla MR scanners from GE Healthcare, consists of two 10-cm square paddles, two 24-cm square paddles, and an eight-channel system interface unit, according to the vendor. The flexible paddles can conform to the areas of interest, MR Instruments said.
An optional single-loop array for the coil suite provides access during MRI interventional procedures and would also be of interest to any facility performing pediatric MRI studies, according to the company.
