Benzinga | Nov 30, 2021 04:42PM EST

Outset Medical's Tablo Hemodialysis System Cartridge Receives FDA Approval For Manufacturing In North America

The FDA has granted 510(k) clearance for Outset Medical Inc's (NASDAQ:OM) new sterilization method of the cartridge utilized in its Tablo 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.

* The new FDA clearance enables Outset to start cartridge production through a manufacturing partner in Mexico, facilitating the localization of the cartridge, in addition to the Tablo console, in North America.

* In addition, the new location reduces the need for expensive and capacity-constrained air freight delivery of the cartridges, thereby simplifying distribution and logistics.

* Another benefit to the FDA clearance is the ability to start using an eco-friendly cartridge sterilization method.

* E-beam is a non-ionizing technology that can be produced on-demand without toxic or potentially explosive chemicals.

* See here Benzinga's Full FDA Calendar.

* Price Action: OM shares closed 5.60% higher at $48.25 on Monday.