Outset Medical Inc

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Products, Other Pre-Announcement

Outset Medical Announces Shipment Hold On New Tablo Systems For Home Use Pending FDA Review And Clearance Of Recent 510(K) Submission

Published: 06/13/2022 21:03 GMT
Outset Medical Inc (OM) - Outset Medical Announces Shipment Hold on New Tablo Systems for Home Use Pending FDA Review and Clearance of Recent 510(k) Submission.
Outset Medical Inc - Outset Has Not Identified Any Safety Issues With Tablo.
Outset Medical Inc - Company Will Continue to Market and Ship Tablo for Use by Healthcare Professionals in Chronic and Acute Care Settings.
Outset Medical Inc - Devices That Are Already Distributed to Home Users Have Not Been Removed.
Outset Medical Inc - As a Result of Shipment Hold, Outset Now Expects Q2 2022 Revenue of at Least $25 Million.
Outset Medical Inc - Company Anticipates an Update on Status of Regulatory Review Process in Q3.
Outset Medical Inc - Company Has Suspended Its Prior Guidance.