Outset Medical Resumes Tablo Hemodialysis Systems Devices Following Hold

Outset Medical has resumed shipment of its Tablo hemodialysis system for home use after the company placed a hold on a shipment in June pending FDA’s 510(k) clearance.

The hold was put in place because of changes made to the device after it initially received FDA’s clearance in March 2020. The updated device has now been cleared by the agency, the company said.

Outset said it did not identify any safety issues and noted that the company continued to market and ship Tablo for use by healthcare professionals in chronic and acute care settings while the hold was in place for home use of the systems.