Outset Medical says FDA grants 510(k) clearance of TabloCart with prefiltration

Outset Medical announced that the U.S. Food and Drug Administration has granted 510(k) clearance of TabloCart with prefiltration, “an innovative optional accessory for the Tablo Hemodialysis System.” Outset has resumed distribution of TabloCart with prefiltration and has product available to ship to customers in the United States. TabloCart is designed to enhance the user experience within healthcare facilities. It comes in two versions: one with added storage and another featuring water prefiltration capabilities, meeting diverse clinical needs, the company stated. “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, Chair and CEO of Outset Medical. “Today’s announcement underscores Outset Medical’s commitment to innovation and our ongoing dedication to transforming the landscape of dialysis treatment.”