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Outset Medical receives FDA nod for dialysis accessory months after halting sales

Outset Medical has obtained 510(k) clearance for TabloCart with prefiltration, an accessory designed to eliminate sediment and minerals from water prior to entering the company’s dialysis machines. Last year, Outset halted the distribution of this accessory following a warning letter from the Food and Drug Administration in July 2023, which required 510(k) clearance.

Based in San Jose, California, Outset competes in the dialysis equipment market. Its Tablo hemodialysis system received clearance for home use in 2020 and is applicable in acute or chronic care settings. The company also produces TabloCart, an accessory for the system equipped with wheels, storage drawers, and water prefiltration, ensuring the removal of sediment and minerals from the supply water before dialysis. This additional prefiltration layer supplements the existing water purification feature in the Tablo system.

Prefiltration of water before dialysis treatment is crucial to prevent patient exposure to pathogens. Outset recorded a 13% year-over-year revenue growth to $130.4 million in 2023, with a net loss of $172.8 million.