# Seno Medical

> Seno Medical develops and commercializes the Imagio Breast Imaging System, which combines opto-acoustic imaging with ultrasound to help trained clinicians characterize breast masses. Its SenoGram AI decision support translates imaging features into an estimated likelihood of malignancy, with the aim of reducing biopsies of benign masses.

- **Founded:** 2005
- **Headquarters:** San Antonio, United States
- **Founders:** Janet Campbell (Founder and former CEO)
- **Products:** Imagio Breast Imaging System, SenoGram, Seno University
- **Notable:** FDA PMA approval on January 11, 2021., Supplemental FDA approval in June 2022., 15-reader retrospective study reported specificity of 47.2% versus 38.2% at fixed 98% sensitivity.

## Products & services

- **Imagio Breast Imaging System** — Diagnostic imaging hardware combining opto-acoustics and ultrasound; original FDA PMA approval in 2021, supplemental approval for the updated system in 2022.
- **SenoGram** — AI-based clinical decision support, available with Imagio, that converts clinician-assigned imaging feature scores and clinical features into a likelihood of malignancy.
- **Seno University** — On-demand virtual education led by A. Thomas Stavros for opto-acoustic interpretation and BI-RADS assessment.

## Achievements

- FDA PMA approval on January 11, 2021.
- Supplemental FDA approval in June 2022.
- 15-reader retrospective study reported specificity of 47.2% versus 38.2% at fixed 98% sensitivity.
- CPT Category III code 0857T effective January 1, 2024.
- Vizient Innovative Technology contract announced November 2024.
- EU MDR CE Mark certification for Model 9100 announced January 26, 2026.

## Latest updates

- **2024-02** — Announced CPT Category III code 0857T, effective January 1, 2024.
- **2024-11** — Announced Vizient Innovative Technology contract; release body dated November 12, listing dated November 24.
- **2026-01** — Announced EU MDR CE Mark certification for next-generation Imagio Model 9100.

## Links

- Website: https://senomedical.com/
- LinkedIn: https://www.linkedin.com/company/seno-medical-instruments/
- Twitter/X: https://twitter.com/senomedical
- Instagram: https://www.instagram.com/senomedical/
- Facebook: https://www.facebook.com/senomedicalinstruments/

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Profile page: https://yespress.io/seno-medical
Published by YesPress — https://yespress.io
Last updated: 2026-10-05