- Outset Medical Inc (NASDAQ:OM) implemented a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending the FDA review and clearance of a 510(k).
- The company submitted for changes made since the device's original March 2020 clearance.
- Outset has not identified any safety issues with Tablo. It will continue to market and ship Tablo for use by healthcare professionals in chronic and acute care settings.
- Devices already distributed to home users have not been removed, and current users can continue working with their healthcare providers on appropriate treatment.
- Related: Outset Medical's Tablo Hemodialysis System Cartridge Receives FDA Approval For Manufacturing In North America.
- As a result of the shipment hold, Outset expects Q2 2022 revenue of at least $25 million.
- The company anticipates an update on the status of the regulatory review process in Q3.
- It will update its 2022 revenue and other financial goals during its next quarterly update in early August.
- Until then, the company has suspended its prior guidance.
- Price Action: OM shares traded 19.75% lower at $16.38 in premarket on the last check Tuesday.
