Outset Medical today announced it has implemented a shipment hold on the distribution of its Tablo haemodialysis system for home use pending the US Food and Drug Administration’s (FDA) review and clearance of a 510(k) the company submitted for changes made since the device’s original March 2020 approval.
Outset has not identified any safety issues with Tablo, according to a press release. The company will continue to market and ship Tablo for use by healthcare professionals in chronic and acute care settings. Devices that are already distributed to home users have not been removed and current users can continue to work with their healthcare providers on appropriate treatment.
As a result of the shipment hold, Outset now expects second quarter 2022 revenue of at least US$25 million. The company anticipates an update on the status of the regulatory review process in the third quarter, and to provide an update to its 2022 revenue and other financial goals during its next quarterly update in early August. Until then, the company has suspended its prior guidance.