Nexalin Backing Senate Bill to Expand Medicare AI Device Reimbursement
Nexalin Technology, Inc., a leader in intracranial frequency stimulation medical devices, has announced its support for the Health Tech Investment Act (S. 1399), bipartisan legislation aimed at expanding Medicare reimbursement for FDA-cleared or approved medical devices that incorporate artificial intelligence (AI) or machine learning technologies. The bill, sponsored by Senators Mike Rounds and Martin Heinrich, proposes a transitional reimbursement mechanism under Medicare that assigns New Technology Ambulatory Payment Classification (APC) codes to AI-enabled devices for up to five years. This transitional period aims to bridge the coverage gap between FDA approval and long-term reimbursement by allowing the Centers for Medicare & Medicaid Services (CMS) to gather additional clinical data.
Nexalin is developing the Gen-3 HALO Clarity™ device, a next-generation neurostimulation system that incorporates advanced AI capabilities for both treatment delivery and patient monitoring. The device targets brain regions associated with anxiety, depression, insomnia, and related mental health conditions using non-invasive, low-frequency waveforms. Complementing the device, Nexalin has created a proprietary virtual clinic ecosystem that leverages AI to enable remote treatment, real-time clinical feedback, and secure data capture through integrated electronic data capture (EDC) and patient monitoring system (PMS) platforms.
The company's AI-powered virtual clinic infrastructure allows patients to start therapy at home via a secure mobile app, while clinicians and researchers receive automated, real-time insights through AI-enabled dashboards. This infrastructure supports Nexalin’s strategy to enhance mental health care delivery with technology-driven solutions and is integral to the launch and use of the Gen-3 HALO Clarity™ device.
The Health Tech Investment Act reflects growing policy recognition of patient-centered, technology-driven innovations in healthcare. If enacted, the bill would provide a clear Medicare reimbursement pathway for AI-enabled medical devices like Nexalin's Gen-3 HALO Clarity™, supporting better care coordination, improved clinical monitoring, and enhanced adherence to treatment protocols. This support is especially relevant in the mental health sector where traditional treatment options often fall short for many patients.
Currently, Nexalin is preparing for FDA submission of the Gen-3 device following planned clinical trials. The company views this legislation as a key regulatory milestone to facilitate device reimbursement and market access. Overall, this bill signals a federal priority toward integrating innovation with accessibility in medical device reimbursement frameworks, which could influence broader acceptance of AI-driven technologies in healthcare delivery.
Nexalin’s earlier generation neurostimulation products have seen approval in international markets including China, Brazil, and Oman. The company's approach leverages deeper penetrating waveforms believed to enhance patient response without adverse side effects, positioning Nexalin as an innovator within the neurostimulation and mental health treatment landscape. The company remains focused on achieving clinical and regulatory milestones in the U.S. and supports the advancement of this legislation to benefit emerging health technologies.