Nexalin Technology Supports Health Tech Investment Act to Enhance Medicare Reimbursement for AI-Enabled Medical Devices
HOUSTON, TX, April 21, 2025 — Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW), a leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, has announced its support for the Health Tech Investment Act (S. 1399). This bipartisan legislation, introduced in the United States Senate, aims to expand Medicare reimbursement opportunities for FDA-cleared or approved medical devices that incorporate artificial intelligence (AI) or machine learning.
The legislation, sponsored by Senators Mike Rounds (R-S.D.) and Martin Heinrich (D-N.M.), proposes a transitional reimbursement mechanism under Medicare to bridge the current gap between device approval and coverage. According to the proposal, AI-enabled technologies receiving FDA clearance or approval would be assigned New Technology Ambulatory Payment Classification (APC) codes for up to five years. This would allow the Centers for Medicare & Medicaid Services (CMS) to collect clinical data and assess long-term reimbursement decisions.
Nexalin’s upcoming Gen-3 HALO Clarity™ device, currently under development for FDA submission, is a next-generation neurostimulation system that 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.
“The Health Tech Investment Act reflects a shift in national health policy toward supporting intelligent, patient-centered innovations,” said Mark White, CEO of Nexalin. “Our Gen-3 HALO Clarity™ device exemplifies this approach by combining precision neurostimulation with AI-driven tools that improve care coordination, monitoring, and adherence. This legislation provides a reimbursement path that recognizes and supports this model of care.”
The Gen-3 HALO Clarity™ device expands upon the clinical foundation laid by Nexalin’s earlier-generation systems, adding intelligent features that allow clinicians to personalize treatment, analyze real-time outcomes, and ensure protocol compliance — whether in the clinic 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 ideally suited to the Gen-3 HALO Clarity™ device. The bill offers a clear signal that federal policymakers are prioritizing the intersection of innovation and accessibility, particularly in areas like mental health where traditional care options remain limited or ineffective for many patients.
As the bill advances through Congress, Nexalin remains focused on its regulatory and clinical milestones while supporting swift bipartisan action to bring this important legislation into law.
About Nexalin Technology, Inc. Nexalin designs and develops innovative neurostimulation products to combat the ongoing global mental health epidemic. All of Nexalin’s products are non-invasive and undetectable to the human body, developed to provide relief to those afflicted with mental health issues. The Company utilizes bioelectronic medical technology to treat mental health disorders and believes its neurostimulation devices can penetrate deep mid-brain structures associated with these conditions.
Forward-looking statements in this press release relate to future events or Nexalin’s future financial performance. These statements are subject to risks and uncertainties that could cause actual events or results to differ materially from those indicated. Readers are advised to review the Risk Factors section of the Company’s Report on Form 10-K for the year ended December 31, 2023, and other filings with the Securities and Exchange Commission for more information.
