Advancing Noninvasive Digital Biomarkers for better patient lives

IMVARIA brings artificial intelligence to imaging and lab data,
re-imagining clinical assessments in serious diseases.

ANNOUNCING FDA AUTHORIZATION FOR FIBRESOLVE:
THE FIRST DIGITAL BIOMARKER IN LUNG FIBROSIS

FIBRESOLVE:
AI for Lung Fibrosis

Fibresolve, IMVARIA's lead AI biomarker, is FDA Breakthrough Designated and Authorized to serve as an adjunct in the diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing.

AI to Better Distinguish IPF from other ILDs:
Fibresolve helps pulmonologists and other qualified clinicians as they work through new diagnosis of patients with suspected ILD including IPF. Fibresolve works like ordering a lab test -- except instead of analyzing blood or tissue, the tool analyzes CT scans for subtle distinguishing patterns based on thousands of points of training data -- what we call a "digital" biopsy.

Supporting Skilled Clinicians:
The results of Fibresolve are intended to be used only by clinicians qualified in the care of lung disease, specifically in caring for patients with ILD, in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.

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the platform

The IMVARIA Digital Biomarker Lab

The Digital Biomarker Lab is a centralized, cloud-based digital lab that operates in a broadly similar fashion to that of a specialty CLIA lab–except that we handle data rather than blood or tissue samples. Clinicians, health systems, and clinical trialists transmit cases to the Lab and IMVARIA analyzes the cases and returns reports with results in minutes. The system capacity crosses imaging modalities (eg. CT, MRI), organ systems, and data types (lab results), and follows international standards for quality compliance (eg. ISO 13485). Projects in new disease areas take weeks to months instead of years, and modern architecture supports deep learning, fusion, and multi-dimensional / multi-modal models.

clinicians and health systems

Clinical Diagnostics

IMVARIA is on the front lines of utilizing digital data to improve patient lives. Leveraging diverse clinical and laboratory datasets to identify distinct disease signatures addresses many of the challenges with standard diagnostic methods.

Additionally, quantitative-only techniques, including many prognostic calculators, rarely capture the complexities and variance of disease phenotypes. With in-house data in more than 30,000 patients, our systems drive new insights in predicting outcomes and helping better understand risks.

life sciences

Digital Biomarkers in Clinical Trials

Through analysis of wide-ranging data types and data sources (including patient registries, clinical trials, and public datasets) the company’s next-generation data science optimizes for consistent and accurate disease assessments and predictions. Whether it is optimizing study enrollment characteristics, better risk-stratifying patients at trial enrollment, or developing predictions for treatment response, IMVARIA can help.

We are proud to work with these partners:

The power of digital biomarkers

Led by dual physician-engineers from Google and Stanford Health Care, IMVARIA’s pioneering work with AI-driven digital biomarkers is redefining how to approach complex diseases more effectively.

Redefining digital biomarkers

Our digital biomarkers provide unique insights into diagnosis and disease assessment, driven by AI and high quality captured clinical data. Imaging and lab results form the basis for more complex analysis of multi-modal clinical data.

MAKING Better decisions

The company is empowering physicians to make the best-informed clinical decisions through the precise application of our digital biomarker technology and data science, taking on the greatest challenges in serious and rare diseases.

Mastering SaMD

IMVARIA's Software-as-Medical-Device (SaMD) tools are transforming the use of digital biomarkers for clinical decision-making and therapeutic development-focused clinical trials.

About IMVARIA

Based in Berkeley, CA, IMVARIA is pioneering AI-driven digital biomarker solutions that empower clinicians to make accurate diagnoses and prognoses at earlier stages of disease and reduce the need for invasive biopsy testing. The company is also using its technology to support biopharmaceutical partners through optimizing pre-trial patient stratification and identifying new digital biomarker opportunities for therapeutics development.

CO-FOUNDER DR. JOSHUA REICHER

Prior experience includes work in Google's AI group, multiple publications in machine learning in medicine, and extensive experience writing code. Dr. Reicher is on clinical faculty as a radiologist and computer science researcher at Stanford / Palo Alto VA.

CO-FOUNDER DR. MICHAEL MUELLY

Prior experience includes work as a Product Manager at Google Cloud's Healthcare group, co-founding of both imaging and network security start-ups, and extensive experience writing code. Dr. Muelly is on clinical faculty as a radiologist and computer science researcher at Stanford.

MEDICAL ADVISOR DR. JOSHUA MOONEY

Leading pulmonary and rare disease expert at Stanford. Board-certified in pulmonary and critical care medicine. Key opinion leader and clinical trials principal investigator.

PRESS

October 6, 2021

Transforming Diagnostics with Machine Learning and Digital Biomarkers

As we’ve seen with the COVID-19 pandemic, diagnostics deliver vital information that enable health providers to properly triage patients and provide the best treatment according to their illness...

June 10, 2021

The UCSF Rosenman Institute Announces the 2021 Rosenman Innovators

The UCSF Rosenman Institute is proud to announce the 2021 cohort of the Rosenman Innovators, a group of early-stage health technology companies chosen for their innovative technologies...

June 15, 2021

MedTech Innovator selects 50 startups for showcase and accelerator program

MedTech Innovator today revealed the 50 startups it selected to partake in its flagship showcase and accelerator program. The four-month program offers the startups visibility and access...

PRESS

October 6, 2021

Transforming Diagnostics with Machine Learning and Digital Biomarkers

As we’ve seen with the COVID-19 pandemic, diagnostics deliver vital information that enable health providers to properly triage patients and provide the best treatment according to their illness...

June 10, 2021

The UCSF Rosenman Institute Announces the 2021 Rosenman Innovators

The UCSF Rosenman Institute is proud to announce the 2021 cohort of the Rosenman Innovators, a group of early-stage health technology companies chosen for their innovative technologies...

June 15, 2021

MedTech Innovator selects 50 startups for showcase and accelerator program

MedTech Innovator today revealed the 50 startups it selected to partake in its flagship showcase and accelerator program. The four-month program offers the startups visibility and access...

January 16, 2024

IMVARIA Announces FDA De Novo Marketing Authorization of Fibresolve, an AI Biomarker in Lung Fibrosis, and the Adoption of Novel CPT Billing Codes by the American Medical Association

BERKELEY, Calif.--(BUSINESS WIRE)--IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the use of Fibresolve, a digital biomarker solution that uses artificial intelligence (AI)...

November 1, 2023

IMVARIA Enters into Know-how Agreement with Mayo Clinic to Improve the Understanding of Cancer through AI Digital Biomarkers

BERKELEY, Calif.--(BUSINESS WIRE)--IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced a collaboration through a know-how agreement with Mayo Clinic to develop AI designed to significantly improve the analysis and understanding of cancer...

May 18, 2023

IMVARIA Announces Data Demonstrating Company’s Non-Invasive Digital Biomarker for Predicting Mortality in Interstitial Lung Diseases

BERKELEY, Calif.--(BUSINESS WIRE)--IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced data from a study evaluating the company’s lead non-invasive digital biomarker Fibresolve showing the tool’s supplemental ability to predict mortality...

April 18, 2023

IMVARIA Announces Presentations at American Thoracic Society International Conference...

IMVARIA Inc., a software-as-medical-device (SaMD) company pioneering AI-driven digital biomarker solutions, today announced that four presentations utilizing the company’s technology will be featured at the upcoming American Thoracic Society 2023 International Conference (ATS 2023)...

August 16, 2022

Aiming Precision Medicine at Chronic Diseases

Chronic diseases cover a wide range of medical conditions from asthma and diabetes to gastrointestinal and heart problems. As the U.S. Center for Disease Control and Prevention (CDC) notes: “Chronic diseases are defined broadly as conditions that last 1 year or more...

October 6, 2021

Transforming Diagnostics with Machine Learning and Digital Biomarkers

As we’ve seen with the COVID-19 pandemic, diagnostics deliver vital information that enable health providers to properly triage patients and provide the best treatment according to their illness...

June 15, 2021

MedTech Innovator selects 50 startups for showcase and accelerator program

MedTech Innovator today revealed the 50 startups it selected to partake in its flagship showcase and accelerator program.The four-month program offers the startups visibility and access to leading manufacturers, providers, investors and other industry stakeholders...

June 10, 2021

The UCSF Rosenman Institute Announces the 2021 Rosenman Innovators

The UCSF Rosenman Institute is proud to announce the 2021 cohort of the Rosenman Innovators, a group of early-stage health technology companies chosen for their innovative technologies and patient impact.2021 is the sixth year for the...

IMVARIA Publications and Abstracts

  • Moran-Mendoza O, Singla A, Kalra A, Muelly M, Reicher JJ. Computed tomography machine learning classifier correlates with mortality in interstitial lung disease. Respir Investig. 2024 May 20;62(4):670-676. [link]
  • Ahmad Y, Mooney J, Allen IE, et al. A machine learning system to indicate diagnosis of idiopathic pulmonary fibrosis non-invasively in challenging cases. Diagnostics (2024). [link]
  • Chang M, Reicher JJ, Kalra A, et al. Analysis of validation performance of a machine learning classifier in interstitial lung disease cases without definite or probable usual interstitial pneumonia pattern on CT using clinical and pathology-supported diagnostic labels. J Digit Imaging. Inform. med. (2024). [link]
  • Bradley J, Huang J, Kalra A, Reicher J. External validation of Fibresolve, a machine-learning algorithm, to non-invasively diagnose idiopathic pulmonary fibrosis. Am J Med Sci. 2023 Dec 24:S0002-9629(23)01475-1. doi: 10.1016/j.amjms.2023.12.009. [link]
  • Maddali M, Kalra A, Muelly M, Reicher J. Development and validation of a CT-based deep learning algorithm to augment non-invasive diagnosis of idiopathic pulmonary fibrosis. Poster presented at: 2023 American Thoracic Society Conference; May, 2023; Washington DC. [link]
  • Ahmad Y, Li J, Mooney J, Allen I, Seaman J, Kalra A, Muelly M, Reicher J. Predicting interstitial pulmonary fibrosis using a machine learning classifier in cases without definite or probable usual interstitial pneumonia pattern on computed tomography. Poster presented at: 2023 American Thoracic Society Conference; May, 2023; Washington DC. [link]
  • Ahmad Y, Mooney J, Allen I, Seaman J, Kalra A, Muelly M, Reicher J. A machine learning system to predict diagnosis of idiopathic pulmonary fibrosis non-invasively in challenging cases. Poster presented at: 2023 American Thoracic Society Conference; May, 2023; Washington DC. [link]
  • Moran Mendoza O, Reicher J, Singla A. Chest computed tomography machine learning classifier for idiopathic pulmonary fibrosis predicts mortality in interstitial lung diseases. Oral presentation at: 2023 American Thoracic Society Conference; May, 2023; Washington DC. [link]
  • Toulomes N, Kalra A, Bradley JA, Gagianas G, Muelly M, Reicher J. Artificial intelligence in incidental detection of lung fibrosis by computed tomography. Oral presentation at: 2023 CHEST Conference; October, 2023; Honolulu, HI. [link]
  • Maddali MV, Kalra A, Muelly M, Reicher JJ. Development and validation of a CT-based deep learning algorithm to augment non-invasive diagnosis of idiopathic pulmonary fibrosis. Respir Med. 2023 Oct 13;219:107428. [link]
  • Selvan KC, Kalra A, Reicher J, Muelly M, Adegunsoye A. Computer-Aided Pulmonary Fibrosis Detection Leveraging an Advanced Artificial Intelligence Triage and Notification Software. J Clin Med Res. 2023 Sep;15(8-9):423-429. [link]

Careers

As a health tech company with a strong clinical and technical founding team with backgrounds at Stanford and Google, we are growing core engineering and commercial teams to build and deploy a medical-grade software platform. You'll get to help shape the trajectory of this mission-driven company, while receiving a hands-on education in building and commercializing medical AI.

IMVARIA is a remote-first company: we welcome flexible schedules, work from home, and digital collaboration. Join us!