CBLL

Ceribell is executing a classic land-and-expand in acute-care EEG, with revenue compounding from $45.2M to $89.1M over two years (36.1% YoY in FY2025) and an 87.9% gross margin that screams platform/software-like unit economics. The MD&A confirms the Ceribell System has been adopted by 'more than 600 hospitals' out of an addressable ~6,000 U.S. acute care facilities — roughly 10% penetration with 90% of the TAM still ahead, supported by an expanding direct U.S. sales force and a CE Mark for Europe.

The pivotal change in the picture is the December 2025 FDA 510(k) clearance for Ceribell's delirium monitoring solution — explicitly described in the MD&A as the 'first and only FDA cleared delirium screening and monitoring device.' Stacked on top of Clarity's May 2023 status-epilepticus clearance, this opens a materially larger acute-care use case (delirium is far more prevalent in ICUs than seizures), and arrives just as the company is scaling its commercial org. That is a real, dated, near-term catalyst that the FY2025 numbers don't yet reflect.