BERKELEY, Calif.– IMVARIA Inc., a health technology company developing AI-driven digital biomarkers, announced it has received a Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The funding will support the development of a new test to improve malignancy assessment in chest CT scans, extending the company’s AI-powered adjunctive diagnostic services into oncology.
The new initiative builds on the success of Fibresolve, IMVARIA’s FDA-authorized AI diagnostic tool for lung disease, and marks a significant step in expanding the company’s medical AI platform. Founded five years ago by physicians with engineering expertise, IMVARIA has focused on creating clinically validated solutions that help physicians make more accurate, non-invasive diagnoses.
“IMVARIA was selected for this NIH SBIR grant because of our innovative technology, two prior FDA authorizations, growing commercial traction, and the strength of our interdisciplinary team,” said Joshua Reicher, M.D., Co-founder and CEO of IMVARIA. “Our Fibresolve service is already making a difference in patient care, giving us the confidence to apply our platform to oncology assessment.”
Each year, more than 1.5 million Americans are found to have indeterminate pulmonary nodules on CT scans. Of those patients, approximately 63,000 are diagnosed with lung cancer within two years, according to NIH data.
With the Phase I SBIR grant, IMVARIA plans to build on early research results presented at the ATS 2025 conference and advance its oncology test toward regulatory-grade performance. The goal is to prepare for clinical trials and, ultimately, make the test available for routine use alongside the company’s existing FDA-authorized services.
“Our long-term mission is to enable better non-invasive diagnoses and generate new insights into patient management across a range of conditions,” said Michael Muelly, M.D., Co-founder and CTO of IMVARIA. “This grant underscores the role AI can play directly in advancing patient care, not just in administrative or backend functions.”
Fibresolve, IMVARIA’s flagship AI service, received FDA authorization in 2024 for use in suspected interstitial lung disease, including idiopathic pulmonary fibrosis. It was the first AI diagnostic tool to achieve both FDA Breakthrough Device designation and CPT billing code adoption by the American Medical Association. Delivered through a centralized platform, Fibresolve is designed to integrate easily into clinical practice while maintaining rigorous medical standards.
“IMVARIA is one of the most innovative healthcare AI companies today,” said Fayez Kheir, M.D., a pulmonologist at Massachusetts General Hospital in Boston. “The NIH grant will accelerate their work in oncology, and I look forward to seeing the outcomes of this important research.”
SBIR grants are designed to stimulate technological innovation by supporting early-stage U.S. companies with promising research and development projects that show commercial potential.
