Sam Brusco, Associate Editor05.06.24
Outset Medical has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for TabloCart with prefiltration, an optional accessory for the Tablo hemodialysis system.
TabloCart, according to the company, was designed to enhance the user experience in healthcare facilities. It comes in two configurations: one with added storage and another with water prefiltration capabilities.
With three customizable prefiltration options, TabloCart adapts to varying water conditions. It also has a booster pump to increase incoming water pressure. 360-degree rotating wheels and directional locking rear wheels help with movement through various clinical environments.
"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.”
Integration of water purification and on-demand dialystate production enables Tablo to be a “dialysis clinic on wheels.” It has two-way wireless data transmission and a proprietary data analytics platform for a new, holistic approach to dialysis care.
Last month, Outset issued a recall—a correction, not a product removal—due to potentially harmful compound leaching from Tablo’s peroxide-cured tubing. There have not yet been injuries or deaths associated with the issue.
TabloCart, according to the company, was designed to enhance the user experience in healthcare facilities. It comes in two configurations: one with added storage and another with water prefiltration capabilities.
With three customizable prefiltration options, TabloCart adapts to varying water conditions. It also has a booster pump to increase incoming water pressure. 360-degree rotating wheels and directional locking rear wheels help with movement through various clinical environments.
"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.”
More about the Tablo hemodialysis system
Tablo is a technological advancement aimed at transforming patients’ dialysis experience and offering simplified operation for providers. A single enterprise solution, it needs only access to tap water and a standard electrical outlet.Integration of water purification and on-demand dialystate production enables Tablo to be a “dialysis clinic on wheels.” It has two-way wireless data transmission and a proprietary data analytics platform for a new, holistic approach to dialysis care.
Last month, Outset issued a recall—a correction, not a product removal—due to potentially harmful compound leaching from Tablo’s peroxide-cured tubing. There have not yet been injuries or deaths associated with the issue.