Seno Medical Instruments, Inc.

Seno Medical Instruments, Inc. is a privately held medical imaging company based in San Antonio, Texas, formed to commercialize a cancer diagnostic modality known as opto-acoustic imaging. The company's core technology fuses laser-generated opto-acoustic signals with conventional ultrasound (OA/US) to visualize functional information in tissue — specifically angiogenesis, the growth of blood vessels and elevated blood volume that surrounds a tumor. Unlike anatomical imaging techniques such as mammography, which primarily show structure, Seno's approach is intended to reveal functional signatures that help clinicians assess whether a breast mass is benign or malignant. The company's flagship product is the Imagio Breast Imaging System, which combines opto-acoustic and ultrasound imaging in a single exam. Imagio is paired with SenoGram, a native, purpose-built AI clinical decision support application that helps radiologists interpret the functional and morphological data. Seno positions Imagio as a new diagnostic pathway intended to reduce the multiple procedures, inconclusive results and negative patient experiences associated with the conventional breast imaging workup, while delivering real-time functional diagnostic imaging and supporting more confident, efficient diagnosis. Seno Medical was founded in 2005 and has assembled a management team with a long history of developing and commercializing medical devices, along with a nationally recognized Medical Advisory Board. The company acquired early opto-acoustic technology and working pre-prototypes, then developed its own prototypes and core patents in the field. Those patents form an expanding platform technology with potential follow-on applications beyond breast cancer, including imaging for the early detection of melanoma, thyroid, prostate and colon cancer. Regulatory and commercial milestones include FDA premarket approval (PMA) for the breast cancer diagnostic imaging technology in 2021, a supplemental PMA in 2022 covering a new ultrasound probe with improved ergonomics, and the first commercial shipment of Imagio for clinical use in the United States in 2023. In 2024 the company was awarded a CPT III code for reimbursement of the OA procedure in the United States and achieved its first commercial shipment of Imagio for clinical use outside the United States. Seno continues to support clinical evidence development, including registry and reader studies, and markets Imagio and SenoGram to breast imaging providers.

Seno Medical Instruments, Inc. was formed in 2005 in San Antonio, Texas, with the goal of commercializing opto-acoustic imaging for cancer diagnosis. The company acquired early opto-acoustic technology and working pre-prototypes, then developed its own prototypes and core patents in the field. According to the company, these patents collectively constitute an expanding platform technology with potential follow-on applications, including imaging for the early detection of melanoma, thyroid, prostate and colon cancer. Seno's first clinical application was breast cancer diagnosis. The company's patented technology integrates lasers and acoustics to determine the presence of angiogenesis — the growth of blood vessels and higher blood volume that surrounds a tumor. Unlike most screening techniques that rely on anatomical imaging, Seno's goal was to bring functional imaging to the marketplace. The company assembled a management team with a long history of developing successfully commercialized medical devices, along with a nationally recognized Medical Advisory Board, to complete commercialization, secure regulatory approval and launch its products. A major regulatory milestone came in 2021, when Seno was granted premarket approval (PMA) for its diagnostic breast cancer imaging technology by the Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration. In 2022, Seno received a supplemental PMA that included a new ultrasound probe incorporating the latest technology to improve ergonomics. That same year, the company shared preliminary results at the European Society of Breast Imaging (EUSOBI) Congress from its CONFIDENCE Registry Study, intended to substantiate the efficacy of the Imagio System in a real-world setting, and published "Optoacoustic Imaging with Decision Support for Differentiation of Benign and Malignant Breast Masses: A 15-Reader Retrospective Study" in the American Journal of Roentgenology. Commercialization advanced in 2023 with the first commercial shipment of Imagio for clinical use in the United States. Also in 2023, neoadjuvant feasibility study results showing promise in detecting vessel and oxygenation changes in the breast to indicate treatment response were shared at the San Antonio Breast Cancer Symposium (SABCS), and health experts from the University of Texas Southwestern Medical Center presented an analysis at the Radiological Society of North America 2023 (RSNA 2023) supporting the cost-effectiveness of using opto-acoustic/ultrasound with AI technology as found in Imagio. In 2024, Seno was awarded a CPT III code for reimbursement of the OA procedure in the United States and achieved its first commercial shipment of Imagio for clinical use outside the United States. The company continues to develop and market the Imagio Breast Imaging System with SenoGram, its native purpose-built AI clinical decision support tool, and to pursue clinical evidence supporting the technology's diagnostic and economic value.

• 2024

  Awarded CPT III code for reimbursement of the OA procedure in the United States; achieved first commercial shipment of Imagio for clinical use outside the United States.

• 2023

  First commercial shipment of Imagio delivered for clinical use in the United States; neoadjuvant feasibility results shared at SABCS; UT Southwestern analysis supporting cost-effectiveness presented at RSNA 2023.

• 2022

  Received supplemental PMA including a new ultrasound probe with improved ergonomics; shared preliminary CONFIDENCE Registry Study results at EUSOBI; published a 15-reader retrospective study in the American Journal of Roentgenology.

• 2021

  Granted premarket approval (PMA) for its diagnostic breast cancer imaging technology by the FDA's Center for Devices and Radiological Health (CDRH).

• 2005

  Seno Medical Instruments, Inc. founded in San Antonio, Texas; timeline begins.

Developer of functional opto-acoustic/ultrasound breast imaging intended to simplify and improve breast cancer diagnosis, paired with native AI decision support.

• Imagio Breast Imaging System

  A hybrid imaging modality that fuses opto-acoustic with ultrasound (OA/US) to provide real-time functional diagnostic imaging and support assessment of whether a breast mass is benign or malignant in a single exam.

• SenoGram

  Seno's native, purpose-built AI clinical decision support application that enhances Imagio.

1. 1Home - Seno Medicalsenomedical.com
2. 2Company Overview - Seno Medicalsenomedical.com
3. 3Careers - Seno Medicalsenomedical.com
4. 4Timeline - Seno Medicalsenomedical.com
5. 5Seno Medical (United States) - Wikidatawikidata.org
6. 6FDA Approves Seno Medical's Ground-Breaking Breast Cancer Diagnostic Technologyfinanznachrichten.de