Benzinga | Nov 30, 2021 04:28PM EST

Outset Medical, Inc. Announces Tablo Hemodialysis System Cartridge Receives FDA 510(k)

Outset Medical, Inc. (NASDAQ:OM) ("Outset"), a medical technology company reducing the cost and complexity of dialysis, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a new sterilization method of the cartridge utilized in its Tablo(r) Hemodialysis System, enabling full production in North America. The Tablo cartridge is a single-use disposable that works in concert with the console to deliver dialysis treatment. Its "one-touch" design speeds and simplifies treatment set-up and take-down.