Nexalin Technology, Inc. announced on April 21, 2025, its strong support for the Health Tech Investment Act (S. 1399), bipartisan legislation introduced in the U.S. Senate. This act aims to expand Medicare reimbursement opportunities for FDA-cleared or approved medical devices that incorporate artificial intelligence (AI) or machine learning.
The proposed legislation suggests a transitional reimbursement mechanism under Medicare, assigning New Technology Ambulatory Payment Classification (APC) codes for up to five years. This period 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, integrates advanced AI capabilities into both treatment delivery and patient monitoring. The company views this act as a legislative milestone that could provide a reimbursement framework ideally suited to its AI-enabled device, which is critical for commercial success in the U.S. market.
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