4DMedical’s Breakthrough in Reimbursement & AI-Driven Lung Imaging: A New Era in Respiratory Diagnostics

The U.S. healthcare landscape is undergoing a transformative shift as artificial intelligence (AI) redefines diagnostic precision and clinical workflows. At the forefront of this revolution is 4DMedical, a pioneer in AI-driven lung imaging, whose recent milestones in Medicare reimbursement and commercial partnerships signal a pivotal inflection point for the company and the broader medical imaging sector. By securing reimbursement for its FDA-cleared CT Lung Ventilation Analysis Software (CT LVAS) and leveraging emerging legislative frameworks, 4DMedical is not only unlocking new revenue streams but also reshaping the economic viability of AI-enabled diagnostics in respiratory care.

Strategic Implications of CMS Reimbursement

The Centers for Medicare & Medicaid Services (CMS) has historically posed a significant barrier for AI-driven medical technologies due to its cautious approach to reimbursement. However, 4DMedical’s breakthrough in August 2025—when CMS approved reimbursement for CT LVAS at a rate of $299 per scan—marks a paradigm shift. This decision validates the clinical utility of 4DMedical’s technology, which overlays detailed ventilation data on standard CT scans, enabling earlier and more accurate diagnoses of conditions like pulmonary embolism, COPD, and pulmonary hypertension [3].

The reimbursement rate itself is strategically significant. At $299 per scan, the pricing aligns with traditional diagnostic imaging services while reflecting the added value of AI-enhanced insights. This creates a sustainable financial model for healthcare providers, incentivizing adoption without overburdening payers. For 4DMedical, the reimbursement opens access to the vast Medicare beneficiary pool, a critical demographic for scaling its AI solutions. By securing its first commercial contract with a U.S. radiology provider in 2025, the company has demonstrated its ability to translate regulatory approvals into real-world revenue [4].

Legislative Tailwinds for AI-Driven Innovation

Beyond CMS’s direct actions, the broader policy environment is aligning to support AI-enabled medical technologies. The Health Tech Investment Act (S. 1399), introduced in April 2025, proposes a new Medicare payment system for algorithm-based healthcare services (AHBS) under a dedicated "technology ambulatory" payment classification (APC). This framework would provide a stable, five-year reimbursement pathway for AI tools like 4DMedical’s CT LVAS, reducing regulatory uncertainty and encouraging long-term investment [1]. While the bill remains in its early stages, its introduction underscores growing bipartisan recognition of AI’s role in modernizing healthcare delivery.

For 4DMedical, this legislative momentum is a strategic multiplier. The company’s existing CMS reimbursement positions it as a prime candidate to benefit from the AHBS framework, should it be enacted. This dual-layered approach—combining immediate reimbursement with forward-looking policy advocacy—creates a robust foundation for market expansion.

Market Expansion and Competitive Positioning

The commercialization of AI-driven lung imaging is still in its infancy, but 4DMedical’s progress highlights its potential to disrupt traditional diagnostic paradigms. By integrating AI into CT scans, the company addresses a critical unmet need: the ability to assess lung function non-invasively and in real time. This capability is particularly valuable in chronic respiratory diseases, where early intervention can significantly reduce healthcare costs and improve patient outcomes.

Moreover, 4DMedical’s partnerships with radiology providers signal industry confidence in its technology. These collaborations not only validate the clinical value of CT LVAS but also accelerate its adoption across healthcare systems. As reimbursement pathways expand, the company is well-positioned to capture a growing share of the $10.2 billion global lung imaging market, which is projected to grow at a compound annual rate of 7.3% through 2030 [5].

Conclusion: A New Era in Respiratory Diagnostics

4DMedical’s achievements in 2025 represent more than a commercial milestone—they signal the dawn of a new era in respiratory diagnostics. By securing CMS reimbursement and aligning with legislative trends, the company has demonstrated that AI-driven imaging can achieve both clinical and economic viability. For investors, this positions 4DMedical as a key player in the AI healthcare revolution, with a clear path to scaling its technology in a rapidly evolving market.

As the Health Tech Investment Act gains traction and reimbursement models for AI mature, 4DMedical’s strategic foresight and regulatory agility will likely translate into sustained growth. The company’s ability to bridge the gap between innovation and practical implementation makes it a compelling case study in how AI can transform healthcare delivery—and profitability.

Source:
[1] Medicare Reimbursement Pathway for AI-Enabled Medical Devices Considered in Senate’s Health Tech Investment Act [https://www.sidley.com/en/insights/newsupdates/2025/05/medicare-reimbursement-pathway-for-ai-enabled-medical-devices-considered]
[2] 4DMedical wins contract to supply lung imaging technology to US radiology company [https://biomelbourne.org/4dmedical-wins-contract-to-supply-lung-imaging-technology-to-us-radiology-company/]
[3] 4DMedical gains US CMS reimbursement for CT LVAS [https://www.listcorp.com/asx/4dx/4dmedical-limited/news/4dmedical-gains-us-cms-reimbursement-for-ct-lvas-3030023.html]
[4] FDA Clears 4DMedical's CT-based Imaging Software | RT [https://respiratory-therapy.com/products-treatment/diagnostics-testing/diagnostics/fda-clears-ct-based-lung-function-scanning-software/]