Free Design Audit Available - Click Here for Details

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

Outset paused shipments of its TabloCart with prefiltration last year after receiving a warning letter from the FDA.

Outset Medical received 510(k) clearance for TabloCart with prefiltration, an accessory that filters sediment and minerals out of water before it enters the company’s dialysis machines.

Outset stopped distributing the accessory last year after receiving a warning letter in July 2023 from the Food and Drug Administration stating that it needed 510(k) clearance.

BTIG analyst Marie Thibault wrote in a research note that the clearance is a “big win” for Outset, adding that she expects the company to now be able to work through a customer backlog.

Sign up for Blog Updates