About Imvaria, Inc
IMVARIA Inc. is a health technology company pioneering AI-driven digital biomarker solutions that empower clinicians to make accurate diagnoses and prognoses at earlier stages of disease while reducing the need for invasive biopsy testing. Founded in 2019 by physician-engineers from Google and Stanford University, the company operates its Digital Biomarker Lab with automated machine-learning algorithm technology to transform clinical decision-making into data science. The company's flagship product, Fibresolve, received FDA De Novo marketing authorization in January 2024 as the first FDA-authorized diagnostic tool in lung fibrosis and the first FDA Breakthrough-Designated AI diagnostic tool with simultaneously adopted CPT billing codes by the American Medical Association. Fibresolve uses artificial intelligence to guide safe, non-invasive diagnosis of lung fibrosis with a focus on idiopathic pulmonary fibrosis (IPF), serving as an adjunct to clinicians in assessing patients with suspected lung fibrosis to provide diagnostic subtype classification. IMVARIA has established a collaboration with Mayo Clinic through a know-how agreement to develop AI designed to improve the analysis and understanding of cancer, beginning with lung cancer. This partnership combines IMVARIA's engineering expertise in digital biomarkers with Mayo Clinic's data assets to discover and validate clinically relevant software-only biomarkers that analyze complex text, numeric values, and medical images. The company is based in Berkeley, California, and continues to advance digital healthcare delivery capabilities through its innovative AI-powered precision medicine approach.
Mission & Story
Mission
To transform clinical decision-making into data science that can help physicians more accurately and rapidly diagnose patients, and therefore, potentially reduce the need for invasive biopsy testing
Founding Story
Founded in 2019 by physician-engineers from Google and Stanford University who combined their expertise in AI, machine learning, and clinical medicine to develop digital biomarker solutions
Clinical Focus
Medical conditions and clinical areas addressed by Imvaria, Inc.
Who It Serves
Milestones & Awards
Recent Milestones
FDA De Novo Marketing Authorization for Fibresolve (January 2024) - first FDA-authorized diagnostic tool in lung fibrosis; FDA Breakthrough Device Designation; AMA adoption of novel CPT billing codes (2024); Mayo Clinic collaboration announced (November 2023); Four presentations at ATS 2023 International Conference (May 2023)
Awards & Recognition
FDA Breakthrough Device Designation; First FDA-authorized diagnostic tool of any type in lung fibrosis; First FDA Breakthrough-Designated AI diagnostic tool with simultaneously adopted CPT billing codes by AMA in any disease
Key Partnerships
Company Details
- Founded
- 2019
- Headquarters
- Berkeley, CA, USA
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