Nexalin Technology (Nasdaq: NXL) has announced its support for the Health Tech Investment Act (S. 1399), a bipartisan legislation that would expand Medicare reimbursement for AI-enabled medical devices. The bill proposes a transitional reimbursement mechanism through New Technology Ambulatory Payment Classification codes for up to five years.
The company’s upcoming Gen-3 HALO Clarity™ device, currently in development for FDA submission, integrates AI capabilities for treating anxiety, depression, and insomnia through non-invasive neurostimulation. Nexalin has completed Phase 1 of its AI-powered virtual clinic infrastructure, enabling home-based therapy initiation and real-time clinical monitoring through a secure mobile app.
The legislation, sponsored by Senators Mike Rounds and Martin Heinrich, aims to bridge the gap between device approval and coverage, supporting Nexalin’s strategy of combining precision neurostimulation with AI-driven healthcare solutions.
Nexalin Technology (Nasdaq: NXL) ha annunciato il suo sostegno al Health Tech Investment Act (S. 1399), una legge bipartisan che mira ad ampliare il rimborso Medicare per dispositivi medici dotati di intelligenza artificiale. Il disegno di legge propone un meccanismo di rimborso transitorio tramite codici New Technology Ambulatory Payment Classification per un periodo fino a cinque anni.
Il prossimo dispositivo Gen-3 HALO Clarity™ dell’azienda, attualmente in fase di sviluppo per la presentazione alla FDA, integra capacità di intelligenza artificiale per il trattamento di ansia, depressione e insonnia tramite neurostimolazione non invasiva. Nexalin ha completato la Fase 1 della sua infrastruttura di clinica virtuale basata su AI, che consente l’avvio della terapia a domicilio e il monitoraggio clinico in tempo reale tramite un’app mobile sicura.
La legge, sponsorizzata dai senatori Mike Rounds e Martin Heinrich, mira a colmare il divario tra l’approvazione dei dispositivi e la loro copertura, supportando la strategia di Nexalin di combinare la neurostimolazione di precisione con soluzioni sanitarie guidate dall’intelligenza artificiale.
Nexalin Technology (Nasdaq: NXL) ha anunciado su apoyo al Health Tech Investment Act (S. 1399), una legislación bipartidista que ampliaría el reembolso de Medicare para dispositivos médicos con inteligencia artificial. La ley propone un mecanismo de reembolso transitorio mediante códigos New Technology Ambulatory Payment Classification por un período de hasta cinco años.
El próximo dispositivo Gen-3 HALO Clarity™ de la compañía, actualmente en desarrollo para su presentación ante la FDA, integra capacidades de inteligencia artificial para tratar ansiedad, depresión e insomnio mediante neuroestimulación no invasiva. Nexalin ha completado la Fase 1 de su infraestructura de clínica virtual potenciada por IA, que permite iniciar la terapia en casa y el monitoreo clínico en tiempo real a través de una aplicación móvil segura.
La legislación, patrocinada por los senadores Mike Rounds y Martin Heinrich, busca cerrar la brecha entre la aprobación del dispositivo y su cobertura, apoyando la estrategia de Nexalin de combinar neuroestimulación de precisión con soluciones de salud impulsadas por IA.
Nexalin Technology (나스닥: NXL)는 AI 지원 의료기기에 대한 메디케어 환급을 확대하는 초당적 법안인 Health Tech Investment Act (S. 1399)를 지지한다고 발표했습니다. 이 법안은 최대 5년간 New Technology Ambulatory Payment Classification 코드를 통한 과도기적 환급 메커니즘을 제안합니다.
현재 FDA 제출을 위해 개발 중인 회사의 차세대 Gen-3 HALO Clarity™ 장치는 불안, 우울증, 불면증 치료를 위한 비침습적 신경자극에 AI 기능을 통합하고 있습니다. Nexalin은 AI 기반 가상 클리닉 인프라의 1단계를 완료하여 안전한 모바일 앱을 통해 가정에서 치료를 시작하고 실시간 임상 모니터링을 가능하게 했습니다.
이 법안은 마이크 라운즈(Mike Rounds)와 마틴 하인리히(Martin Heinrich) 상원의원이 후원하며, 기기 승인과 보험 적용 간의 격차를 해소하는 것을 목표로 하며, Nexalin의 정밀 신경자극과 AI 기반 헬스케어 솔루션 결합 전략을 지원합니다.
Nexalin Technology (Nasdaq : NXL) a annoncé son soutien au Health Tech Investment Act (S. 1399), une loi bipartite visant à étendre le remboursement Medicare pour les dispositifs médicaux équipés d’intelligence artificielle. Le projet de loi propose un mécanisme de remboursement transitoire via des codes New Technology Ambulatory Payment Classification pour une durée pouvant aller jusqu’à cinq ans.
Le futur dispositif Gen-3 HALO Clarity™ de la société, actuellement en développement pour une soumission à la FDA, intègre des capacités d’IA pour traiter l’anxiété, la dépression et l’insomnie grâce à une neurostimulation non invasive. Nexalin a achevé la phase 1 de son infrastructure de clinique virtuelle alimentée par l’IA, permettant le démarrage de la thérapie à domicile et la surveillance clinique en temps réel via une application mobile sécurisée.
Cette législation, parrainée par les sénateurs Mike Rounds et Martin Heinrich, vise à combler le fossé entre l’approbation des dispositifs et leur prise en charge, soutenant la stratégie de Nexalin qui combine neurostimulation de précision et solutions de santé pilotées par l’IA.
Nexalin Technology (Nasdaq: NXL) hat seine Unterstützung für den Health Tech Investment Act (S. 1399) angekündigt, ein parteiübergreifendes Gesetz, das die Medicare-Erstattung für KI-gestützte medizinische Geräte erweitern würde. Der Gesetzentwurf sieht einen Übergangs-Erstattungsmechanismus über New Technology Ambulatory Payment Classification Codes für bis zu fünf Jahre vor.
Das kommende Gen-3 HALO Clarity™-Gerät des Unternehmens, das sich derzeit in der Entwicklung zur FDA-Einreichung befindet, integriert KI-Fähigkeiten zur Behandlung von Angstzuständen, Depressionen und Schlaflosigkeit durch nicht-invasive Neurostimulation. Nexalin hat Phase 1 seiner KI-basierten virtuellen Klinik-Infrastruktur abgeschlossen, die die Therapieeinleitung zu Hause und die Echtzeit-Überwachung der klinischen Daten über eine sichere mobile App ermöglicht.
Die Gesetzgebung, gesponsert von den Senatoren Mike Rounds und Martin Heinrich, zielt darauf ab, die Lücke zwischen Gerätezulassung und Kostenerstattung zu schließen und unterstützt Nexalins Strategie, präzise Neurostimulation mit KI-gesteuerten Gesundheitslösungen zu kombinieren.
Positive
- Potential Medicare reimbursement pathway for up to 5 years through new legislation
- Completed Phase 1 of AI-powered virtual clinic infrastructure
- Development of advanced AI-integrated medical device targeting multiple mental health conditions
Negative
- Gen-3 HALO Clarity device still pending FDA submission and approval
- Reimbursement depends on passage of legislation that is still under consideration
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.
Contact:
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FAQ
What is the potential impact of the Health Tech Investment Act on Nexalin’s (NXL) Medicare reimbursement?
The Act would provide up to 5 years of transitional Medicare reimbursement for Nexalin’s AI-enabled devices through New Technology APC codes, bridging the gap between FDA approval and coverage determination.
How does Nexalin’s (NXL) Gen-3 HALO Clarity device incorporate AI technology?
The device integrates AI for treatment delivery, patient monitoring, and provides real-time clinical feedback through a virtual clinic ecosystem with secure data capture capabilities.
What mental health conditions will Nexalin’s (NXL) Gen-3 HALO Clarity device target?
The device is designed to treat anxiety, depression, insomnia, and related mental health conditions through non-invasive, low-frequency neurostimulation.
What is the current development status of Nexalin’s (NXL) Gen-3 HALO Clarity device?
The device is under development for FDA submission, with Phase 1 of its AI-powered virtual clinic infrastructure already completed.
