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Home » Outset Medical stock down on shipment hold news

Outset Medical stock down on shipment hold news

June 14, 2022 By Chris Newmarker

Outset Medical logoOutset Medical (Nasdaq: OM) stock lost about a third of its value today — a day after the company said it was holding shipments of its Tablo hemodialysis system for home use.

OM shares were down more than 34% to $13.46 apiece by the close of trading today.  MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly.

The San Jose, California–based company said the shipment hold was the result of a pending FDA review and clearance of a 510(k) submitted for changes made since the Tablo system’s original March 2020 clearance.

Outset Medical said it has not identified any safety issues with Tablo — and will continue to ship the device for use in chronic and acute healthcare settings. The company has not removed already distributed devices from home, and current users can continue to work with their healthcare providers on appropriate treatment.

As a result of the shipment hold, Outset Medical suspended prior guidance and said it now expects Q2 revenue of at least $25 million; Wall Street analysts had expected $34.1 million.

Outset Medical expects an update on the regulatory review process in Q3, with plans to update its full-year guidance in early August.

Filed Under: 510(k), Business/Financial News, Dialysis, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Outset Medical

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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