IMVARIA's AI Nabs Big Investment to Reshape Lung Diagnostics

📊 Key Data
  • $XX Million Investment: IMVARIA secures significant funding led by InHealth Ventures and Labcorp Venture Fund to expand AI-driven lung diagnostics.
  • FDA Breakthrough Device Designation: IMVARIA's Fibresolve received this status in 2024 for its potential to improve ILD diagnosis.
  • CPT Billing Codes Adoption: First for an FDA Breakthrough-Designated AI diagnostic, enabling standardized reimbursement.
🎯 Expert Consensus

Experts view IMVARIA's AI-driven diagnostic tools as a transformative advancement in lung disease detection, with strong industry backing validating its potential to enhance clinical outcomes and efficiency.

4 days ago

IMVARIA's AI Nabs Big Investment to Reshape Lung Diagnostics

BERKELEY, CA – January 07, 2026 – IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced a significant strategic investment set to accelerate the adoption of artificial intelligence in clinical diagnostics. The funding round was led by InHealth Ventures (IHV), the early-stage fund linked to the prominent UK diagnostics provider InHealth Group, with significant participation from the Labcorp Venture Fund and existing partner Cedar Crest Holdings. This infusion of capital is earmarked to expand the reach of IMVARIA's AI-powered diagnostic services for lung disease and fuel the company's next wave of innovation.

Founded in 2019 by physician-engineers from Google and Stanford University, the Berkeley-based firm has rapidly distinguished itself in the crowded health tech space. By focusing on turning complex medical images into actionable data science, IMVARIA aims to empower clinicians with tools for earlier and more accurate diagnoses, starting with some of the most challenging respiratory conditions.

The Strategic Significance of a High-Profile Backing

The identities of the new investors are as significant as the investment itself, signaling strong market validation from established healthcare giants. InHealth Ventures' lead role provides IMVARIA with a powerful ally and a potential gateway into the European healthcare market. As the venture arm of a leading screening and diagnostics provider, IHV’s investment is more than financial; it's a strategic alignment.

“At InHealth, we have confidence in IMVARIA’s health AI innovation and their medical credibility,” said Richard Bradford, Chair of InHealth Group, in a statement. He described the partnership as part of a “broader plan that we have to harness the power of AI to equip doctors and allied health professionals with more powerful tools and tests to transform how chronic disease is identified and treated.”

The participation of the Labcorp Venture Fund further solidifies IMVARIA's position. Labcorp is a global titan in laboratory services, and its venture arm is tasked with identifying and nurturing innovations that can reshape the diagnostic landscape. This investment suggests a deep synergy, as Labcorp’s strategic goals—making healthcare more convenient, data-driven, and personalized—mirror IMVARIA's mission. For many of Labcorp's portfolio companies, the investment is a prelude to deeper operational collaborations, which could provide IMVARIA with unparalleled access to a vast diagnostic infrastructure and clinician network.

“Our investment in IMVARIA reflects a shared vision for how AI can improve patient care through fast and efficient diagnostics,” commented Megann Vaughn Watters, Vice President of New Ventures and Strategic Alliances for Labcorp. This backing from two major industry players underscores a growing consensus: AI is no longer a peripheral technology but a core component of the future of diagnostic medicine.

A New Frontier in Lung Disease Diagnostics

At the heart of IMVARIA's success is Fibresolve, its flagship AI-powered test service. The technology addresses a critical unmet need in diagnosing interstitial lung disease (ILD), a group of over 200 disorders characterized by scarring of the lungs, including the particularly aggressive idiopathic pulmonary fibrosis (IPF). Traditionally, diagnosing these conditions can be a long, arduous process involving invasive procedures and a high degree of diagnostic uncertainty.

Fibresolve uses sophisticated machine-learning algorithms to analyze standard chest CT scans, providing clinicians with new insights to guide a safe, non-invasive diagnosis. The platform's clinical utility and rigor were validated in early 2024 when it received authorization from the U.S. Food and Drug Administration (FDA). Even more impressively, it was granted FDA Breakthrough Device Designation, a status reserved for technologies that may provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.

However, IMVARIA's most significant commercial milestone may be its simultaneous adoption of CPT billing codes by the American Medical Association (AMA). This achievement, a first for an FDA Breakthrough-Designated AI diagnostic in any disease, is a game-changer. It effectively bridges the gap between technological innovation and practical clinical use by creating a clear, standardized pathway for reimbursement. This removes a major barrier to adoption, making it financially viable for hospitals and clinics to integrate the service into their standard of care.

Making AI Accessible for Clinicians and Patients

IMVARIA's founders, who are both practicing physicians and former Google engineers, have embedded a deep understanding of clinical workflow into the company's DNA. This unique perspective has been crucial in designing a tool that is not only powerful but also practical.

“We have made AI-driven testing for lung conditions extremely easy for pulmonologists to get new insights about patients that will help them have a richer set of data for making their own assessments,” explained Michael Muelly, MD, Co-founder and CTO of IMVARIA. The company operates Fibresolve as a centralized service, meaning clinicians can simply order the AI analysis without needing to install new software, manage complex IT integrations, or undergo extensive training. This 'service-based' model minimizes the burden on busy clinicians and healthcare systems.

This focus on usability, combined with the streamlined reimbursement offered by the CPT codes, directly enhances patient access. Patients with suspected ILD can potentially receive a more confident diagnosis faster, without the risks and costs associated with invasive surgical biopsies. The company estimates its non-invasive approach could save thousands of dollars per patient, a compelling value proposition for a healthcare system increasingly focused on both outcomes and efficiency. Multi-site clinical experience has already demonstrated the tool's adoption and utility in real-world pulmonology practices.

Beyond the Lungs: A Platform Poised for Expansion

While IMVARIA has made its name in pulmonary disease, its ambitions extend far beyond. The company's AI platform was designed to be adaptable, and the new strategic funding will help fuel its expansion into other critical areas of medicine, most notably oncology.

A clear signal of this expansion came in late 2025 when the company was awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). This funding is dedicated to developing a new test for more accurate malignancy assessment in chest CTs, leveraging the same core technology that powers Fibresolve to tackle lung cancer detection.

This builds on a growing pipeline of products, including ScreenDx, another AI tool for ILD assessment that received FDA 510(k) clearance in 2025, and Bronchosolve, a solution for lung cancer diagnosis that has already met its primary endpoints in a pivotal study. This demonstrates a clear and deliberate strategy to build a comprehensive suite of AI-driven diagnostic tools.

“We are currently focusing on non-invasive diagnoses for lung diseases, but we are also looking at opportunities to expand the applications of our AI platform and algorithms to support and help accelerate the evolution of healthcare,” stated Joshua Reicher, MD, Co-founder and CEO of IMVARIA. With this new capital and the backing of powerful industry partners, the company is now strongly positioned to execute on that vision, potentially transforming diagnostic paradigms across multiple fields of medicine.

📝 This article is still being updated

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