Outset Medical’s Dialysis System Gets Additional FDA Clearance

The FDA granted Outset Medical 510(k) clearance for its Tablo hemodialysis system for home use.

The device was previously cleared for use in acute and chronic care facilities, but the new clearance allows it to be used by healthcare providers in a patient’s home.

Outset highlighted the increased need for home dialysis during the COVID-19 pandemic and said the product will improve patient outcomes while lowering cost.