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B. Braun receives FDA product approval
Stacy Wescoe//August 27, 2020//
Listen to this articleB. Braun Medical Inc. of Bethlehem said it has received U.S. Food and Drug Administration approval for a new product.
The company has received 510(k) clearance for its SpaceStation MRI, which allow Space infusion pumps to continuously deliver medications to patients within an MRI suite.
The MRI is designed to shield Space infusion pumps against magnetic fields to protect the scanner and provide interference-free images.
Long infusion lines are no longer needed with the product.
“Clearance of the SpaceStation MRI represents a significant development for patients and healthcare providers,” said Angela Karpf, MD, corporate vice president for medical affairs at B. Braun Medical. “It will allow patients to be safely transitioned into the MRI suite without the interruption of infusion therapy since there is no need to switch to an alternative pump.
