Commercial Adoption And Margin ResilienceStrong commercial traction, raised revenue guidance, an expanded sales force, and a new production line that reduces tariff exposure support scalable adoption and improved profitability.
Regulatory ExpansionFDA clearances for delirium plus neonatal and pediatric indications expand the addressable market and establish the system as the first US‑approved device for delirium screening and monitoring.
Technology Platform And Reimbursement PathwayA proprietary AI Clarity algorithm, breakthrough designation for large vessel occlusion stroke, and a submitted NTAP application position the platform to address multiple clinical indications and boost potential reimbursement.