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FDA Approvals - MEDRAD Receives FDA 510(k) Clearance For Wireless MR Infusion System


MEDRAD Receives FDA 510(k) Clearance For Wireless MR Infusion System (Medical News Today)
MEDRAD, INC., announced that the wireless version of its Continuum MR Infusion System has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The new Continuum Wireless MR Infusion System enables the clinician to control a patient's medication infusion during a magnetic resonance (MR) procedure from both inside and outside the scan room.

St. Jude Medical Receives U.S. and European Approvals of EonC, the First Extended-Life Primary Cell Neurostimulator ... (Centre Daily Times)
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals of EonC(TM), the first extended-life primary cell (non-rechargeable) neurostimulator for the treatment of chronic pain.

FDA Approves Registration Of AbSorber's Transplantation Test (Medical News Today)
The Swedish biotech company AbSorber has been given clearance by the U.S. Food and Drug Administration (FDA) to market and sell its XM-ONE transplantation test in the U.S. Initially, sales of XM-ONE in the U.S. will target the kidney transplantation market valued at approximately SEK 200 million. XM-ONE previously received CE marking and is approved for sales within the EU.
 

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