Companies / Invenio Imaging

Medical device company profile

Invenio Imaging

California medical device company combining stimulated Raman histology with AI-assisted analysis of fresh surgical and biopsy tissue.

Medical Device Manufacturer and DeveloperDiagnostics & ImagingDiagnostic Imaging

Headquarters🇺🇸San Jose, California, United States

Founded2012

Commercial statusCommercially availableCommercial NIO imaging platform; Glioma Reveal available in Europe and Lung Cancer Reveal investigational in the United States.

Employees11–50 ^[3]LinkedIn company-size range · Checked 2026-11-04

Estimated revenueNot confirmed

Official websitewww.invenio-imaging.com ↗

Company overview

Invenio Imaging is a San Jose, California medical device company founded in 2012. Led by CEO and co-founder Jay Trautman, it develops the NIO imaging platform to examine fresh tissue rapidly without conventional freezing, sectioning or staining. Adrian Whitford serves as President.

The NIO system uses stimulated Raman histology to produce digital tissue images for review and sharing. The company also develops application-specific AI modules, including Glioma Reveal for brain-tumor tissue and Lung Cancer Reveal for bronchoscopic biopsy specimens.

The imaging platform is commercially deployed, and Glioma Reveal is CE-marked and available for clinical use in Europe. Lung Cancer Reveal remains investigational in the United States. In August 2026, Invenio reported completion of enrollment in its 1,006-patient ON-SITE pivotal study to support regulatory submission.

^{[1][2][3][4][5][6]}

Leadership

6 people

Jay Trautman, PhDChief Executive Officer & Co-founder ^[2]

Chris Freudiger, PhDChief Technology Officer & Co-founder ^[2]

Adrian WhitfordPresident ^[2]

Steven Pastore, MDVice President, Clinical Affairs ^[2]

Adrian Ion-Margineanu, PhDHead of Artificial Intelligence Development ^[2]

Geoff ManiagoManager, Manufacturing ^[2]

Products & regulatory status How does MedTechIndex get this information?

Summary

Invenio’s NIO imaging platform and AI modules have distinct regulatory positions. The company states that Glioma Reveal is CE-marked and available for clinical use in Europe. That status does not extend automatically to Lung Cancer Reveal or establish U.S. authorization of an AI module. ^[6][4]

Lung Cancer Reveal received FDA Breakthrough Device Designation but remains investigational in the United States. Its intended output flags morphology suspicious for cancer in NIO images and is not intended to serve as the primary diagnosis. ^[4]

The ON-SITE study enrolled 1,006 patients at seven centers and collected more than 3,250 fresh biopsy specimens. Invenio’s August 2026 announcement described enrollment completion and planned analysis for regulatory submission, rather than an authorization decision or published validation result. ^[4]

Regulatory snapshot How to read this snapshot

U.S. FDA

—
510(k) clearances: —
De Novo grants: —
PMA approvals: —
Recall events

Latest recorded source review: 2026-11-04.

Scope: selected product families.

Commercial portfolio snapshot

Documented commercial product families.

Invenio NIO Laser Imaging System with monitor and imaging console — Image: Invenio Imaging

Fresh-tissue imaging and analysis platform

NIO imaging and AI analysis platform ↗

Stimulated Raman histology imaging system with digital tissue-image review and application-specific AI modules. Glioma Reveal is available for clinical use in Europe; Lung Cancer Reveal is investigational in the United States. ^[1]

Commercial imaging platform · AI status varies by module and region