Outset Medical, Inc., also known as OM, has announced that the U.S. Food and Drug Administration (FDA) has granted a 510(k) clearance for their product TabloCart with prefiltration. This is an optional accessory for the Tablo Hemodialysis System. This product features three customizable prefiltration options, making it adaptable to differing water conditions. With the clearance from the FDA, Outset has been able to resume the distribution of TabloCart with prefiltration and currently has a ready product for shipping to clients in the U.S
Leslie Trigg, the CEO of Outset Medical, commented on this milestone saying, "With the FDA's clearance of TabloCart with prefiltration, we have succeeded in adding features to the Tablo Hemodialysis System. These increase its flexibility, making it easier for nurses and health systems to cater to patients in both the ICU and bedside.”
Outset Medical's shares witnessed a rise by 11% in pre-market trade on Monday.
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