Outset Medical, a leading med tech innovator delivering first-of-its-kind technology into the growing global dialysis market, today announced the Food and Drug Administration (FDA) cleared the Tablo Hemodialysis System for patient use in the home. The new home clearance expands Tablo’s existing labeled indication for use in acute and chronic care facilities, which for the first time enables healthcare providers the same dialysis machine from the ICU to the home.
Tablo enters the market at a critical time in the midst of the COVID-19 pandemic and renewed national focus on home dialysis for improving patient outcomes while lowering cost.In mid-2019, President Trump and United States Department of Health and Human Services Secretary Alex Azar announced an Executive Order to help Americans with kidney failure. A major component of the policy was ensuring 80% of all new dialysis patients start therapy at home or get transplanted by 2025. The emergence of COVID-19 further heightens the urgency for giving current in-center dialysis patients the option to treat at home.
“Tablo was designed to simplify dialysis, making it easier and more accessible for patients to take advantage of the safety, convenience and flexibility of dialyzing at home,” said Outset Medical Chief Executive Officer, Leslie Trigg. “We are proud to offer them this new, life-enhancing option, particularly in light of the COVID-19 related challenges dialysis patients and providers are experiencing.”
Currently, more than 500,000 Americans undergo dialysis treatments three or more times each week, typically lasting four hours per treatment. Approximately 100,000 new patients start treatment annually. Yet only 12% receive it at home where they’re more comfortable, productive and empowered.
See Full Press Release: Tablo® Hemodialysis System Receives FDA Clearance for Home Dialysis
Written by: Outset Medical, Inc.
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