E-Z-EM gets FDA nod for EmpowerMR injector

E-Z-EM has received 510(k) clearance from the FDA for its EmpowerMR injector system, the company's first product for the MR market. The company’s previous emphasis and products have been in the CT injector systems with its Empower products.

EmpowerMR has an interface and safety features similar to the other products in the Empower line. EmpowerMR also employs several features designed to cope with the problem of electrical interference in the magnetic field of the MR scanner.

Electromechanical devices like injector systems can create both electric and magnetic fields that cause electrical interference with the MR scanner during the imaging process, leading to image distortion or artifacts. To minimize this problem, EmpowerMR employs a patent-pending hydraulic control system instead of the shielded electrical control components used by most other MR injectors systems.

EmpowerMR has no shielded iron core motors, piezoelectric motors or electrically active motor control circuitry adjacent to the scanner, which minimizes the prospect of electrical interference with the scanner's magnetic field. EmpowerMR also provides for utilization in MR field strengths up to 7 Tesla.

EmpowerMR is not battery operated, and links to its electrical supply by a single pass-through cable that does not require special shielding. As there is no motor in the MR suite, EmpowerMR does not generate audible noise. EmpowerMR's hydraulic control also means the system can deliver consistent flow rates, volumetric and pressure performance on demand-features which may help improve productivity in the MR suite.