Shares of dialysis solutions provider Outset Medical (NASDAQ:OM) are trending lower today after it received a Warning Letter from the U.S. Food and Drug Administration (FDA) for its Tablo hemodialysis system.
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Outset had previously received four inspectional observations from the regulatory body and completed the necessary remediation measures. Now, the FDA has flagged two additional concerns.
The first observation notes that certain materials on Outset’s website promote CRRT (continuous renal replacement therapy) which is outside the present indications for the company’s Tablo hemodialysis system. The second concern notes that the TabloCart necessitates a prior 510(k) clearance.
Outset noted that the first observation has already been effectively addressed and plans to engage with the FDA to resolve the second observation. Importantly, this could mean a potential 510(k) submission for TabloCart.
Importantly, the FDA has not sought the withdrawal or any restrictions on Outset’s Tablo System. Shares of the company have now tanked nearly 18.2% over the past month while short interest in the stock is now hovering above 15%.
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