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 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.