Outset Medical, Inc. (NYSE:OM) shares plunged 34% on Tuesday following the company’s announcement, according to which it made a shipment hold on Tablo for home use pending U.S. Food and Drug Administration (FDA) review and clearance of the recent 510(K) submission. An update on the status of the regulatory review process is estimated in Q3/22.

The company now anticipates Q2/22 revenue of at least $25 million (vs. Street’s $34 million). Simultaneously, the company suspended its 2022 guidance. Existing home units and acute and chronic shipments are unaffected.