After experiencing trouble with observations in February, Outset Medical has received a new warning from the Food and Drug Administration (FDA). In the warning letter, the agency references the Tablo hemodialysis system and its accessory, the TabloCart.
Firstly, the agency raised an issue with the firm’s promotion of continuous renal replacement therapy (CRRT) based on material published on its website, especially since the Tablo dialysis system hasn’t been cleared to provide this therapy. CRRT is a slowed-down version of standard dialysis that takes up to a day to fully clean the patient’s blood, compared to a few hours.
In response, Outset has claimed to have made labeling and promotional changes that adequately address the agency’s concerns.
The other issue identified by the FDA concerns a Tablo accessory called the TabloCart, which adds 360-degree rotating wheels to the machines. This feature was launched last year and, according to the FDA, requires additional regulatory clearance. The agency demands that a 510(k) clearance for marketing authorization be filed for the feature, which can provide prefiltration for the water used in dialysate mixtures.
The company has announced its full collaboration with the FDA to resolve the highlighted problems and ensure a response within the given 15-day deadline. However, the firm has not specified the timing of any of the mentioned resolutions.
Despite no guarantee that Outset’s responses would satisfy the FDA, the agency has not attempted to restrict Tablo’s manufacturing, production, or shipment in the U.S., nor has it requested the company to withdraw its system from the U.S. market.
Furthermore, in February of this year, Outset Medical, based in San Jose, California, announced an FDA form-483 in its annual report, in which the agency made four inspectional observations. The observation highlighting these issues occurred on February 10, 2023, and a response plan was announced at the beginning of March. The response plan included complete remediation workstreams aimed at resolving the mentioned issues.
Prior to this, in the summer of last year, Outset was forced to put a hold on its home-use Tablo Hemodialysis system pending FDA review. Shortly after, the company faced a shareholder lawsuit claiming that executives had made misleading statements about the matters leading to the shipment holdup, painting a rosier picture than the truth. When the company was finally able to resume shipments, a class-action securities lawsuit arose.
These consecutive issues resulted in the company’s stocks plummeting to an all-time low of around $13 in June 2022.