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FDA Sends Warning To Outset Medical Concerning Two Issues With Its Dialysis Device

 
• By Brian Bossetta

The US Food and Drug Administration sent a warning letter to Outset Medical citing two concerns with the Tablo Hemodialysis System. Outset disclosed the letter in a recent filing with the US Securities and Exchange Commission.

Warning Letter
• Source: Shutterstock

In a 5 July warning letter to Outset Medical, the US Food and Drug Administration cited two concerns with the company’s Tablo Hemodialysis System, which is designed to treat kidney disease at home.

The agency’s first concern relates to materials on the company’s website that promote continuous renal replacement therapy (CRRT), a slower type of dialysis that puts less stress on the heart....

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