Outset Medical rebounds on new FDA clearance for dialysis cart

Don’t call it a comeback—technically, it’s a whole new regulatory clearance. Outset Medical has resumed distributing its portable dialysis machine after halting sales last summer, now that it’s obtained a necessary green light from the FDA.

The company halted shipments of part of its Tablo hemodialysis systems this past August, after the agency handed down a warning letter saying that a piece of optional hardware would need to complete its 510(k) review process—namely, the wheeled TabloCart accessory that offers onboard prefiltration of the water used in dialysis delivery.

With that clearance in hand, Outset Medical saw its stock soar nearly 60% at its peak after the news, before the share price settled down to a healthy 20% gain by the end of the day’s trading, ultimately landing at $3.79.

“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,” Outset CEO Leslie Trigg said in the company’s announcement.

The TabloCart comes in two flavors: one with extra storage and one with prefiltration. Previously the company said it determined the latter did not require an FDA marketing authorization. The agency’s warning letter disagreed, but it did not raise any issues with the Tablo system’s overall safety, efficacy or quality. 

The letter did, however, take issue with claims on Outset’s website, which had promoted a slowed-down version of dialysis known as continuous renal replacement therapy—an indication that the Tablo has not received clearance for, though the system is OK’d for use up to 24 hours.

It’s not the company’s first back-and-forth with the agency. Outset previously paused Tablo shipments in mid-2022 for about six weeks—specifically the systems built for at-home use—as it awaited a renewed FDA clearance following changes made to its design in the years after its first green light in 2020.