Proposed bipartisan legislation would expand Medicare reimbursement pathways for AI-enabled medical devices — a framework that supports Nexalin’s Gen-3 HALO Clarity™ neurostimulation device integrated with artificial intelligence
HOUSTON, TX, April 21, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced its support for the Health Tech Investment Act (S. 1399) — bipartisan legislation introduced in the United States Senate that would 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 close the current gap between device approval and coverage. Under the proposal, AI-enabled technologies that receive FDA clearance or approval would be assigned New Technology Ambulatory Payment Classification (APC) codes for up to five years, allowing time for 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 that target key brain regions associated with anxiety, depression, insomnia, and related mental health conditions. In tandem with the device itself, Nexalin has built a proprietary virtual clinic ecosystem that utilizes artificial intelligence to support remote treatment, real-time clinical feedback, and secure data capture — all through an integrated Electronic Data Capture (EDC) platform and Patient Monitoring System (PMS).
The Company recently completed Phase 1 of its AI-powered virtual clinic infrastructure, which enables patients to initiate therapy at home via a secure mobile app, while clinicians and researchers receive automated, real-time insights through AI-enabled dashboards. This ecosystem is engineered specifically to support the Gen-3 HALO Clarity™ device and is a core component of Nexalin’s strategy to enhance mental health care through technology-driven solutions.
“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 that approach — 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 has been designed to meet the needs of both patients and providers in an increasingly digital healthcare environment. It 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. The Company 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, especially 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 and supports swift bipartisan action to bring this important legislation into law.
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin’s products are non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, and Oman. Additional information about the Company is available at: https://nexalin.com/.
Forward-looking statements
This press release contains statements that constitute “forward-looking statements,” These statements relate to future events or Nexalin’s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that Nexalin or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward-looking statements that involve risks and uncertainties which could cause actual events or Nexalin’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Report on Form 10-K for the year ended December 31, 2023, and other filings as filed with the Securities and Exchange Commission. Copies of such filings are available on the SEC’s website, www.sec.gov. Such forward-looking statements are made as of the date hereof and may become outdated over time. Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
