Outset Medical has paused shipment of its Tablo Hemodialysis System for home use as the Food and Drug Administration reviews recent changes to the system’s original design.
Outset Medical Chairman and CEO Leslie Trigg told analysts during an investors call late Monday the FDA is reviewing information from a human factor data study, along with other test data, to clear the system for home use. Trigg said the company has not identified any safety issues with the equipment.
“Devices that are already distributed to home users have not been removed from use, and current users can continue to work with their healthcare providers on appropriate treatment strategies,” Trigg said on the call.
The FDA review is expected to be completed sometime in the third quarter. Trigg said the Tablo device can continue to be used in dialysis facilities, and she continued to express optimism for the home dialysis market.
Outset Medical introduced the Tablo system for home use in the spring of 2020. Last summer it announced a partnership with nonprofit kidney care firm Satellite Healthcare to drive hemodialysis into homes by leveraging Satellite’s network of 80 dialysis centers in five states.
Home dialysis has been on the rise since former President Donald Trump launched the Advancing American Kidney Health initiative in 2019. The plan set a goal of 80% of patients newly diagnosed with End Stage Renal Disease dialyzing at home by 2025.
