Nexalin Technology Supports Health Tech Investment Act for AI-Enabled Medical Devices
Nexalin Technology, Inc. (Nasdaq: NXL) has announced its strong support for the Health Tech Investment Act (S. 1399), a bipartisan legislation introduced in the United States Senate. The bill aims to expand Medicare reimbursement opportunities for FDA-cleared or approved medical devices that incorporate artificial intelligence (AI) or machine learning.
The proposed legislation, sponsored by Senators Mike Rounds (R-S.D.) and Martin Heinrich (D-N.M.), suggests a transitional reimbursement mechanism under Medicare. This mechanism would assign New Technology Ambulatory Payment Classification (APC) codes for up to five years to AI-enabled technologies that receive FDA clearance or approval. This provision is designed to bridge the current gap between device approval and coverage determination, allowing the Centers for Medicare & Medicaid Services (CMS) time to collect clinical data and assess long-term reimbursement decisions.
Nexalin’s upcoming Gen-3 HALO Clarity™ device, currently under development for FDA submission, exemplifies the type of innovation the Health Tech Investment Act aims to support. This next-generation neurostimulation system integrates advanced AI capabilities into both treatment delivery and patient monitoring. The device is designed to deliver non-invasive, low-frequency waveforms targeting key brain regions associated with anxiety, depression, insomnia, and related mental health conditions.
In conjunction with the Gen-3 HALO Clarity™ device, Nexalin has developed a proprietary virtual clinic ecosystem. This AI-powered infrastructure enables remote treatment, real-time clinical feedback, and secure data capture through an integrated Electronic Data Capture (EDC) platform and Patient Monitoring System (PMS). The Company has recently completed Phase 1 of this virtual clinic infrastructure, allowing patients to initiate therapy at home via a secure mobile app while clinicians receive automated, real-time insights through AI-enabled dashboards.
“The Health Tech Investment Act represents a significant shift in national health policy toward supporting intelligent, patient-centered innovations,” said Mark White, CEO of Nexalin. “Our Gen-3 HALO Clarity™ device embodies this approach by combining precision neurostimulation with AI-driven tools that enhance care coordination, monitoring, and adherence. This legislation provides a crucial reimbursement pathway that recognizes and supports this model of care.”
The Gen-3 HALO Clarity™ device builds upon the clinical foundation established by Nexalin’s earlier-generation systems. It incorporates intelligent features that allow clinicians to personalize treatment, analyze real-time outcomes, and ensure protocol compliance, whether in clinical settings or remotely. Nexalin is currently preparing for FDA submission of the Gen-3 device following planned clinical trials.
Nexalin views the Health Tech Investment Act as a legislative milestone that could provide a reimbursement framework well-suited to the Gen-3 HALO Clarity™ device. The bill signals that federal policymakers are prioritizing the intersection of innovation and accessibility, particularly in areas like mental health where traditional care options often fall short.
As the bill progresses through Congress, Nexalin remains focused on its regulatory and clinical milestones while supporting swift bipartisan action to enact this important legislation.
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to address the global mental health epidemic. The company’s non-invasive and undetectable devices utilize bioelectronic medical technology to treat mental health issues. Nexalin’s neurostimulation medical devices are designed to penetrate deep mid-brain structures associated with mental health disorders, potentially generating enhanced patient response without adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman.
