By Stephen Nakrosis
Shares of Outset Medical Inc. are down in Monday’s late trading session after the medical technology company said it had implemented a shipping hold on the distribution of its system of Tablo hemodialysis for home use pending U.S. Food and Drug Administration review and clearance.
The company said it submitted a 510(k) for “changes made since the device was originally authorized in March 2020.” The FDA said medical device manufacturers must submit a premarket notification, or 501(k), “if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be substantially changed or modified to the extent that its safety or effectiveness could be affected.”
The company said it has not identified any safety issues with Tablo and will continue to market and ship Tablo “for use by healthcare professionals in chronic and acute care settings.” The company also said that following the suspension of shipments, it now expects revenue of at least $25 million for the second quarter of 2022. The company said revenue of $30.6 million in the first quarter.
As of 5:30 p.m. ET, shares of the company were trading down 21.56% at $16.01 per share. The stock ended the day’s regular session with a loss of 2.81%, closing at $20.41 per share.
Write to Stephen Nakrosis at [email protected]