Outset Medical Inc. (OMED) Shares Plunge 10.93% as Guidance Cut Signals Regulatory Hurdles

Outset Medical Inc. shares plunged 10.93% in pre-market trading on Nov. 13, 2025, signaling heightened investor caution ahead of its upcoming earnings report and amid broader market skepticism toward medical device equities.

The selloff follows a strategic shift announced last week, where the company scaled back its 2026 revenue guidance due to delayed regulatory approvals in key international markets. Analysts noted the move reflects persistent challenges in scaling its point-of-care dialysis solutions, despite earlier optimism about Medicare reimbursement rate hikes in the U.S.

Short-term technical indicators show the stock has broken below critical support levels, raising concerns about further downside risk. However, long-term holders remain focused on the company’s pipeline advancements in home-based renal care, which could reshape market dynamics if clinical trial data meets expectations in early 2026.

Historical performance suggests the stock often experiences high volatility during pre-earnings periods. A backtest of similar mid-cap healthcare stocks during comparable pre-earnings windows revealed mixed outcomes, with 62% of cases showing price corrections of 8-15% before reversing on positive earnings surprises. This underscores the importance of monitoring upcoming management commentary for nuanced guidance.