Outset Medical, Inc. (OM) announced the U.S. FDA has granted 510(k) clearance of TabloCart with prefiltration, an optional accessory for the Tablo Hemodialysis System. With three customizable prefiltration options, TabloCart is designed to adapt to varying water conditions. Outset has resumed distribution of TabloCart with prefiltration and has product available to ship to customers in the U.S.
"With the FDA's clearance of TabloCart with prefiltration, we have delivered features to the Tablo Hemodialysis System that increase the flexibility for nurses and health systems to serve patients from the ICU to the bedside," said Leslie Trigg, CEO of Outset Medical.
Shares of Outset Medical are up 11% in pre-market trade on Monday.
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