Tablo® Hemodialysis System Cartridge Receives FDA 510(k) Clearance Enabling Production in North America

Tuesday, November 30, 2021

Outset Medical, Inc., a medical technology company reducing the cost and complexity of dialysis, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a new sterilization method of the cartridge utilized in its Tablo® Hemodialysis System, enabling full production in North America. The Tablo cartridge is a single-use disposable that works in concert with the console to deliver dialysis treatment. Its “one-touch” design speeds and simplifies treatment set-up and take-down.

The new FDA clearance enables Outset to start cartridge production through a manufacturing partner in Mexico, facilitating the localization of the cartridge, in addition to the Tablo console, in North America. In addition, the new location reduces the need for expensive and capacity-constrained air freight delivery of the cartridges, thereby simplifying distribution and logistics for the company, its customers and patients.

“This clearance is an important milestone on our roadmap to continued gross margin expansion,” said Leslie Trigg, President and Chief Executive Officer of Outset. “In addition to cost reduction, we also are now better able to optimize our manufacturing process and mitigate current supply chain challenges around lead time, capacity and logistics.”

Another benefit to the FDA clearance is the ability to start using an eco-friendly cartridge sterilization method. E-beam is a non-ionizing technology that can be produced on-demand and does not involve toxic or potentially explosive chemicals. Further details on Outset’s sustainability efforts can be found in the company’s recently published ESG Report.

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