Nexalin Technology Expresses Strong Support for Health Tech Investment Act to Advance Medicare Reimbursement for AI-Enabled Devices

Core Viewpoint - Proposed bipartisan legislation, the Health Tech Investment Act, aims to expand Medicare reimbursement pathways for AI-enabled medical devices, supporting Nexalin's Gen-3 HALO Clarity™ neurostimulation device integrated with AI [1][2] Group 1: Legislation Overview - The Health Tech Investment Act (S. 1399) is sponsored by Senators Mike Rounds and Martin Heinrich, proposing a transitional reimbursement mechanism under Medicare for FDA-cleared or approved AI-enabled technologies [2] - The legislation would assign New Technology Ambulatory Payment Classification (APC) codes for up to five years to AI-enabled devices, allowing CMS to collect clinical data for long-term reimbursement decisions [2] Group 2: Nexalin's Gen-3 HALO Clarity™ Device - Nexalin's Gen-3 HALO Clarity™ device is a next-generation neurostimulation system that integrates advanced AI capabilities for treatment delivery and patient monitoring, targeting mental health conditions such as anxiety and depression [3][5] - The device is designed to work with a proprietary virtual clinic ecosystem that utilizes AI for remote treatment and real-time clinical feedback, enhancing mental health care through technology [4][5] Group 3: Strategic Importance of Legislation - The Health Tech Investment Act is viewed as a legislative milestone that prioritizes innovation and accessibility in mental health care, addressing the limitations of traditional care options [6] - The legislation provides a reimbursement framework that aligns with Nexalin's strategy to enhance care coordination and monitoring through intelligent, patient-centered innovations [5][6] Group 4: Company Developments - Nexalin has completed Phase 1 of its AI-powered virtual clinic infrastructure, allowing patients to initiate therapy at home via a secure mobile app while providing clinicians with automated insights [4] - The company is preparing for FDA submission of the Gen-3 device following planned clinical trials, indicating a focus on regulatory and clinical milestones [7]