MEDRAD announced today that it has received FDA clearance for use of its Continuum MR Infusion System in MR environments up to and including 3.0 Tesla (T). The new FDA clearance enables clinicians working in the latest 3.0T environments to infuse medications, sedatives, and other drugs, workflow and dose enhancements, the company said.
Continuum was introduced in 2002 in an effort to meet what the company viewed as a need for safe and reliable infusion during MRI procedures in strengths up to 1.5T, the market standard at the time. Now with higher strength magnets widely available, MEDRAD began testing in 3.0T, and Continuum is now cleared to provide guidance for safety and performance in that environment. MR accessory equipment must meet safety standards and perform without interfering with the quality of medical images. Tests for attraction, homogeneity, artifact, and static magnetic field are designed to ensure that Continuum meets or exceeds these requirements, and the results confirm that it does, the company said.
In the most recent enhancement to Continuum, MEDRAD added a greater selection of drug-specific units of measurement, increasing the number of drugs that can be infused. It also helps prevent programming errors by reducing the confusion of manual conversions.