Outset Medical halts home Tablo shipments pending FDA 510(k) review; guides Q2 rev at least $25M

Outset Medical, Inc.

Shipment hold on new Tablo Hemodialysis Systems for home use pending FDA 510(k) clearance of post-March 2020 changes.
Q2 2022 revenue expected at least $25M; prior FY2022 guidance suspended until early August update.
No safety issues identified; Tablo continues to sell for chronic and acute care settings.
Already-distributed home devices not removed; current users can continue treatment with providers.
Company expects update on regulatory review process in Q3 2022.

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