Outset Medical announced that it won expanded FDA clearance for patient use in the home with its Tablo hemodialysis system.
Tablo’s existing indication included use in acute and chronic care facilities but, amid the COVID-19 pandemic, can now offer hemodialysis treatment from the home as in-hospital treatment is more of a challenge under current circumstances.
Outset’s Tablo system is designed to use wireless data, sensor-based automation and an animated touchscreen to make dialysis care accessible in-home, requiring only an electrical outlet and tap water to operate. The all-in-one dialysis machine, which handles both water purification and dialysate production, is designed to be used in a variety of settings.
“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.” Outset Medical CEO Leslie Trigg said in a news release. “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.”
The demand for in-home dialysis treatment continues to grow after, in July 2019, the Trump administration revealed its plan to overhaul the way kidney disease is treated in the U.S., looking to increase early detection and emphasize transplants and home hemodialysis instead of in-clinic treatment.
In October 2019, Tablo won a contract from the U.S. Dept. of Health & Human Services for use in response to natural disasters. In February of this year, the company announced that it raised $125 million in a Series E equity financing round to help support the commercial expansion of Tablo in the U.S.
Other dialysis treatment developers are adjusting during the COVID-19 pandemic, as Fresenius (NYSE:FMS) and DaVita Healthcare (NYSE:DVA) announced a collaboration to offer isolation capacity for dialysis patients who are or may be COVID-19-positive.
The goal of the collaboration is to maintain continuity of care for dialysis patients and to keep them out of the hospital whenever possible to free up limited hospital resources, according to a news release.