Request A Demo

Clinical | Clinical Trials

Welcome to the Seno Medical Clinical Trials page - Find information on studies sponsored by Seno Medical Instruments and registered on www.clinicaltrials.gov.

Seno’s goal is to bring functional imaging that can detect the development of new blood vessels (angiogenesis) to the marketplace as an indicator of potential cancerous concern. Clinical trials are an essential component of our research and the evolution of our products being commercially available for patient use.

You can learn more about these studies below or by going to the respective study record page on ClinicalTrials.gov.

NOTE: The Imagio® OA technology has been studied for feasibility — but not yet approved in the diagnosis — of thyroid abnormalities and for use in monitoring breast masses undergoing neoadjuvant treatment.

Questions for the team? Reach out today

"This is real science. These are real effects, real data, and it really works."

View an interview excerpt on clinical trials from Dr. Michael Linver

Clinical Evaluation of Opto-Acoustic Image Quality with the Second Generation Imagio® System
This study performed the first clinical evaluation of the Gen 2 Imagio® System in a clinical setting to assess image quality with both the Imagio® ultrasound only probe and the OA/US duplex probe. Approved by the U.S. FDA in January 2021, this device received supplemental PMA approval in June of 2022, CE mark in the European Union is pending.
Learn More
Imagio® Opto-Acoustic Versus Imagio® Ultrasound (Reader-02 Pivotal)
The Imagio® Pivotal Study was an independent reader study using the images from the PIONEER Study and was designed to evaluate the safety and efficacy of the Imagio® Breast Imaging System, including the SenoGram® AI decision support tool. The study concluded that Imagio® Breast Imaging System reduces false positives and thus biopsies of benign masses compared to grayscale ultrasound alone at an equivalent sensitivity. Approved by the U.S. FDA in January 2021, this device received supplemental PMA approval in June of 2022, CE mark in the European Union is pending.
Read the Study Learn More
Imaging with Opto-Acoustics to Downgrade BI-RADS Classification Relative to Other Diagnostic Methodologies (MAESTRO)
MAESTRO is a European Post Marketing Study that was designed to assess the ability of OA to effectively downgrade benign masses and upgrade malignant masses. Benign masses (particularly those classified as BI-RADS 4a) can be downgraded to BI-RADS 3 or 2 with confidence, potentially decreasing negative biopsies and short interval follow-up imaging exams. This medical device has CE-marking and is approved in Europe and other nations.
Read the Study Learn More
Pioneer Pivotal Study of the Imagio® Breast Imaging System
Imagio® is a hybrid modality device comprised of opto-acoustic (OA) imaging co-registered with diagnostic gray-scale (B mode) ultrasound that has been designed to concurrently collect OA images in conjunction with diagnostic gray-scale (B-mode) ultrasound.
Read the Study Learn More

Imagio® is FDA approved for commercial distribution in the U.S. and ready for your patients. Contact our Sales Department today.

Review some of our frequently asked questions on our FAQ page or read our eBook.

Get closer to understanding the clinical journey for opto-acoustics through our Clinical Publications Bibliography.