Ceribell, Inc. 8-K

What Happened

• On January 5, 2026, Ceribell, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for Ceribell’s Large Vessel Occlusion (LVO) stroke detection and monitoring solution. The company filed an 8-K and attached a press release (Exhibit 99.1). The filing was signed by CFO Scott Blumberg.

Key Details

• Date of filing/report: January 5, 2026.
• Event: FDA granted Breakthrough Device Designation for Ceribell’s LVO stroke detection and monitoring solution.
• Disclosure: Announcement was made via press release attached to the 8-K (Exhibit 99.1).
• Formally reported in SEC Form 8-K under Item 8.01 (Other Events).

Why It Matters

• Breakthrough Device Designation is a regulatory status intended to help accelerate the development and review of devices that address serious or life‑threatening conditions. For investors, the designation can mean faster, more focused interaction with the FDA and potential acceleration toward commercial availability — factors that can affect product timelines and competitive positioning. This 8-K is a factual notice of the designation; the filing does not provide new financial guidance, revenue figures, or changes to management.