Tablo Hemodialysis System Receives FDA Clearance for Home Use


Outset Medical announced that it received FDA 510(k) clearance for its Tablo Hemodialysis System to be used in the home, expanding its existing labeled indication for use in acute and chronic care facilities.

Touted by Outset as a “dialysis clinic on wheels,” Tablo is designed to reduce dialysis cost and complexity. The device needs only an electrical outlet and tap water to operate, as it includes water purification and dialysate production on demand. A touchscreen tablet guides the user through setup and treatment, and it can also upload data to the cloud for clinician access. Tablo features automated self-cleaning, an integrated blood pressure cuff, and treatment duration flexibility ranging from 30 minutes to 12 hours.

Over half a million
Americans receive dialysis at least three times per week, according to Outset
Medical, with each treatment lasting about four hours. This presents a
significant time and economic burden for patients who rely on long-term dialysis
for kidney failure. And with the emergence of COVID-19, the company points out,
home hemodialysis is even more important.

According to the company,
Tablo will be rolled out for home use at select sites over the coming months.

“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 Leslie Trigg, Outset Medical Chief
Executive Officer, in a statement. “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.”

Check out this video tour of Tablo:

Product page: Tablo

Flashback: Tablo Dialysis Machine Simple Enough for Patients to Use Themselves

Via: Outset

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