Why Shares of Outset Medical Are Down Monday
Shares of Outset Medical (NASDAQ: OM) were down 9% as of 11:30 a.m. ET after falling as much as 12% on news the company had received a warning letter from the Food and Drug Administration (FDA). The stock is down more than 27% so far this year.
Outset is a medical technology company focusing on dialysis care. In a Securities and Exchange Commission filing on Friday, the company said it had received a Warning Letter from the FDA on July 5 regarding the company's Tablo Hemodialysis System. The letter came from a FDA inspection of Outset on Feb. 10. While Outset provided a response plan after the inspection, the FDA's Warning Letter raised two new concerns. The first was that the company was promoting on its website that the Tablo Hemodialysis System could provide continuous renal replacement therapy, though that is outside the scope of system's current indications. The FDA also said the TabloCart with Prefiltration requires prior 510(k) clearance for marketing authorization.
The company said it plans to work with the FDA quickly to resolve the concerns, including the potential submission of a 510(k) on the TabloCart.
Source Fool.com
