Nexalin Backs AI Device Legislation for Medicare Reimbursement
Washington D.C., Monday, 21 April 2025.
Nexalin supports a bill to expand Medicare reimbursement for AI medical devices, enhancing innovation and backing its Gen-3 HALO Clarity™ neurostimulation system. This marks a shift in health tech policy.
Bipartisan Push for AI Healthcare Innovation
The Health Tech Investment Act (S. 1399), introduced by Senators Mike Rounds (R-S.D.) and Martin Heinrich (D-N.M.), represents a significant shift in healthcare policy. The legislation aims to create a transitional reimbursement mechanism under Medicare for FDA-cleared or approved AI-enabled medical devices [1]. This development comes at a crucial time when regulatory frameworks are evolving to accommodate AI in healthcare, as evidenced by recent FDA draft guidance on AI-enabled medical devices [4].
Next-Generation Neurostimulation Technology
Nexalin’s Gen-3 HALO Clarity™ device exemplifies the innovative potential this legislation aims to support. The system combines precision neurostimulation with AI-driven capabilities for treatment delivery and patient monitoring [1]. Building on the company’s existing presence in international markets, where its Gen-2 15 milliamp device has already secured approvals in China, Brazil, and Oman [1], the new system represents a significant advancement in neurostimulation technology.
Implementation and Market Impact
The proposed legislation addresses a critical gap between device approval and coverage, potentially accelerating the adoption of AI-enabled medical technologies [1]. Mark White, CEO of Nexalin, emphasizes that the device is designed to meet the evolving needs of a digital healthcare environment, enabling personalized treatment protocols and real-time outcome analysis [1]. These capabilities align with broader healthcare trends toward data-driven, personalized medicine approaches [GPT].
Future Outlook and Regulatory Pathway
As Nexalin prepares for FDA submission following planned clinical trials [1], the timing of the Health Tech Investment Act could provide crucial support for innovative medical devices. The legislation’s focus on expanding reimbursement pathways [1] comes as healthcare providers increasingly seek solutions that can improve care coordination and treatment adherence [GPT]. This regulatory evolution suggests a growing recognition of AI’s role in advancing medical treatment modalities [alert! ‘specific timeline for FDA approval process not specified in sources’].