Healthcare Industry News: IRadimed
News Release - March 22, 2006
IRadimed Corporation Announces CE, UL, Siemens, and Philips Certification for Its MRidium(TM) MRI Infusion Pump SystemWINTER PARK, Fla., March 22 (HSMN NewsFeed) -- IRadimed Corporation announced today it has received a number of new certifications for its award-winning MRidium(TM) MRI Infusion Pump System. These new certifications allow for IRadimed to sell in a number of key new markets both internationally and domestically.
The recently acquired CE mark allows IRadimed Corporation to sell its MRidium(TM) MR Infusion Systems into all European community (EC) countries - which includes the major components of the European market and is helpful in other countries around the world. The CE mark is an international standard of quality for products sold into specific countries in the international market. IRadimed has local sales coverage in most of these key European community countries.
UL 60601-1 listing provides IRadimed the ability to sell into a number of key markets in the United States which require products to have UL recognition and approval before entering their facilities. Infusion Pumps are now tested under a set of requirements by UL which review in depth: flow accuracy, battery life, labeling, product integrity, and much more; not just the power safety checks as with other products. "Compliance with this new UL 60601-1 standard is a testimony to the integrity and quality of the MRidium(TM) Infusion System," says Fran Casey, VP of Quality Assurance and Regulatory Affairs.
IRadimed also received certification from both Siemens and Philips that the MRidium(TM) MRI Infusion Pump System is compatible with their 1.0 to 3.0 T MRI systems. Both Siemens and Phillips perform testing looking for non-magnetic properties and image distortion due to CTL Noise, Imaging Artifacts, EPT spike noise, and general compatibility in regards to the MRI environment. The 3850 MRidium(TM) MRI Infusion Pump has qualified independent confirmation that it provides safe, artifact-free infusion using a non-magnetic motor and MR tight case design.
The MRidium(TM) MRI Infusion System from IRadimed Corporation is the first large volume infusion pump system designed from the ground up for use in 0.2 to 3.0 T MRIs. It provides hospitals with the ability to deliver fluids via syringes, standard IV tubing, and a unique bypass infusion set for changing over IVs without having to disconnect from the patients. IRadimed recently launched its new remote control feature which allows clinicians and physicians to monitor and adjust IVs such as Propofol for sedation while remaining in the MR control room.
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