[1] The company was founded by C. David Finch, Jr., MD[3] and Jeffrey H. Burbank in December 1998.

It received Food and Drug Administration clearance for home hemodialysis in June 2005.

[6] On November 2, 2005, the company received the Nixon Peabody/Smith&Nephew Medical Device Innovation Award in the Start-Up category from the Massachusetts Medical Device Industry Council (MassMEDIC).

[7] In December 2014, the company received Food and Drug Administration clearance for System One to be used overnight while patients are sleeping.

[8] In August 2017, the company received Food and Drug Administration clearance for System One for solo home hemodialysis, without a care partner, during waking hours.