New Brain Assessment System Launches in US
A new functional brain assessment system has rolled out in the United States. The system is designed to provide clinicians with advanced tools for evaluating brain function and health, expanding the diagnostic capabilities available for neurological conditions.
- The Delphi MD system from QuantalX Neuroscience, which received FDA De Novo classification, is designed to measure the function of brain networks in real-time. The non-invasive assessment takes approximately 30-40 minutes and provides a standardized report to help clinicians identify subtle network changes not visible in structural scans. The system is also covered by a dedicated CPT reimbursement code. - Another recent entrant is the WAVi system, which utilizes an FDA-cleared EEG headset to measure brain wave patterns, heart rate variability, and cognitive response through auditory and visual event-related potentials (ERPs). The portable system allows for rapid setup and testing, with scans taking as little as four minutes to complete. - The broader diagnostic imaging market is experiencing a significant shift from hospital settings to outpatient centers, with outpatient imaging growth now outpacing the overall radiology market. Approximately 40% of all radiology volume is now performed in outpatient imaging centers or clinics. - This shift to outpatient settings is driven by the need for more convenient and cost-effective care, leading health systems to invest in smaller-footprint, high-performance imaging equipment suitable for clinics or mobile units. In some regions, like Baltimore, as much as 91% of certain imaging procedures like mammography occurs outside of hospitals. - Projections for the next decade indicate that standard outpatient imaging volume is expected to grow by about 10%, while advanced imaging is projected to increase by nearly 14%. The overall U.S. diagnostic imaging services market is forecasted to grow from USD 149.54 billion in 2025 to USD 239.74 billion by 2032. - Reimbursement for cognitive health assessments is evolving, with recent changes to Medicare Advantage (MA) coding and classification. The newer CMS-HCC V28 model has expanded coding for dementia, creating more incentives for providers to conduct routine cognitive screenings. - Despite the push for new technologies, some Medicare contractors have proposed denying coverage for certain AI-based brain MRI analysis tools, citing insufficient evidence of clinical utility. This could impact reimbursement for technologies that automatically detect and quantify changes in brain scans for neurodegenerative diseases. - The rise of the "neurohospitalist" subspecialty reflects the increasing complexity of inpatient neurological care and the need for dedicated expertise in the hospital setting. This trend is driven by a focus on cost-effectiveness, quality metrics, and managing complex neurological inpatients.
