Welcome to the Seno Medical Clinical Trials page where you will find information on studies sponsored by Seno Medical Instruments and registered on www.clinicaltrials.gov.

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 at clinicaltrials.gov

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.

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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.

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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.

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