Press Releases

Study found OA/US fused imaging significantly improved specificity at fixed sensitivity compared to conventional ultrasound 

[SAN ANTONIO, TX – January 5, 2023] A retrospective study of Seno Medical‘s Imagio^® Breast Imaging System published in the American Journal of Roentgenology found that the company’s opto-acoustic/ultrasound (OA/US) technology significantly improves specificity at fixed sensitivity compared to conventional ultrasound. The study, Optoacoustic Imaging with Decision Support for Differentiation of Benign and Malignant Breast Masses: A 15-Reader Retrospective Study, shows that optoacoustic imaging with decision support may help reduce biopsies of benign breast masses compared with grayscale ultrasound interpretation alone, while maintaining 98 percent sensitivity for cancer.

Led by Stephen Seiler, MD, University Texas Southwestern Medical Center, Dallas, TX, the study’s objective was to compare ultrasound images alone and fused OA/US images for specificity at a fixed sensitivity evaluated with machine learning-based decision support tool (DST) assistance. The reader study included 480 patients with 480 breast masses that had been classified by conventional grayscale ultrasound. Fifteen readers independently reviewed the acquired images after training in OA/US imaging interpretation. 

Specificity at fixed sensitivity of 98 percent was significantly higher for OA/US images with DST assistance than for ultrasound alone (47.2 percent vs 38.2 percent). Better performance for fused OA/US images with DST assistance than for ultrasound was observed for 14 out of 15 readers. All readers (15/15) partial area under the curve was statistically higher for OA/US with DST than for ultrasound alone.

The authors of the study concluded that, “Fixed ultrasound and optoacoustic images with DST assistance provided significantly improved specificity at fixed sensitivity compared with conventional ultrasound alone.”

Recently honored with a Gold Edison award, a Gold Medical Design Excellence Award and as a semi-finalist in the 2022 Minnies for its medical innovation, Seno’s groundbreaking diagnostic breast cancer imaging system helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic/ultrasound (OA/US) technology to provide information on breast lesions in real time, helping providers to characterize masses that may — or may not — require more invasive diagnostic evaluation. 

Breast biopsy procedures caused by false-positive diagnostic assessments cost the US healthcare system more than $2 billion per year.ⁱ Seno’s Imagio^® technology could significantly reduce those costs with its patient-centric OA/US innovation.

Seno’s OA/US system combines laser optics and grayscale ultrasound to provide fused functional, morphological, and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer — angiogenesis and hypoxia — Seno Medical has shown that the Imagio^® OA/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio^® System, Seno includes an artificial intelligence (AI) decision-support tool (SenoGram^®) to help physicians interpret the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging to more precisely assign the likelihood of malignancy. 

The system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Originally approved by the US FDA in January 2021 with a Supplemental PMA Approval for its latest device in June 2022, Seno Medical’s Imagio^® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

###

ⁱ Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoeconomics Outcomes Res 2018;10:157-167.

The category defining Imagio^® Breast Imaging System helps physicians differentiate between benign and malignant breast lesions using a novel combination of ultrasound and opto-acoustic technology.

[SAN ANTONIO, TX – November 27, 2022] Seno Medical, makers of the Imagio^® Breast Imaging System - a revolutionary new modality in breast imaging - will officially launch the commercially available system at the annual RSNA Scientific Assembly and Annual Meeting starting November 27 through December 1 in Chicago (Booth 6120). Recently recognized with a Gold Edison award, a Gold Medical Design Excellence Award, and as a semifinalist in the Minnies 2022 competition for its medical innovation, Seno’s groundbreaking diagnostic breast cancer imaging system helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic/ultrasound (OA/US) technology to provide information about breast lesions in real time, helping providers to characterize masses that may — or may not — require more invasive diagnostic evaluation.

In support of the launch at RSNA, Seno Medical will bring its category-defining Imagio^® System to the doorsteps of clinicians and healthcare providers throughout the USA with its mobile education and demonstration tour, Imagio^® OA/US Road Show - Scans Across America. The hands-on tour, which began this summer and is scheduling stops across the country throughout the coming year, enables on-site demonstrations of the Imagio^® System. (www.experienceimagio.com/tour/)

The market-ready Imagio^® System received supplemental premarket approval (PMA) from the Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA) in June of this year; it incorporates the latest in ultrasound imaging technology required for premier breast imaging centers, as well as advanced ultrasound technology integrated into the opto-acoustic probe, a new ultrasound probe, and elimination of redundant electronics, making this version of Imagio^® ergonomic and truly disruptive for the marketplace with its novel technological advances.

Tom Umbel, President and CEO of Seno Medical, commented, “The time has come for the market to start adopting and using this groundbreaking new hybrid modality for breast imaging, and we are proud to be showcasing it at RSNA.”

Breast biopsy procedures, caused by false-positive diagnostic assessments, cost the US healthcare system more than $2 billion per year.ⁱ Seno’s Imagio^® technology could significantly reduce those costs with its non-invasive OA/US innovation.

Seno’s OA/US system combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer — angiogenesis and hypoxia — Seno Medical has shown that the Imagio^® OA/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio^® System, Seno includes an artificial intelligence (AI) decision-support tool (SenoGram^®) to aid physicians in interpreting the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto- acoustic imaging. Originally approved by the US FDA in January 2021, Seno Medical’s Imagio^® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

###

Indication statement: The Imagio^® system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.
 

ⁱ Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoeconomics Outcomes Res 2018;10:157-1

(SAN ANTONIO, TX – August 9, 2022) Seno Medical will bring its category-defining Imagio^® Breast Imaging System to the doorsteps of clinicians and healthcare providers throughout the US with the launch of its Scans Across America hands-on experience tour starting in August (www.experienceimagio.com/tour/). Recently honored with a Gold Edison Award as well as a Gold Medical Design Excellence Award for its medical innovation, Seno’s groundbreaking diagnostic breast cancer imaging system helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic/ultrasound (OA/US) technology to provide information on breast lesions in real time, helping providers to characterize masses that may — or may not — require more invasive diagnostic evaluation.

Breast biopsy procedures caused by false-positive diagnostic assessments cost the US healthcare system more than $2 billion per year.ⁱ Seno’s Imagio^® technology could significantly reduce those costs with its patient-centric OA/US innovation.

Seno’s OA/US system combines laser optics and grayscale ultrasound to provide fused functional, morphological, and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer — angiogenesis and hypoxia — Seno Medical has shown that the Imagio^® OA/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio^® System, Seno includes an artificial intelligence (AI) decision-support tool (SenoGram^®) to help physicians interpret the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging to more precisely assign the likelihood of malignancy.

The system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.

The Imagio^® OA/US Road Show — Scans Across America tour will feature continued stops across the country throughout 2022. To request a tour stop or to find out more, please visit www.experienceimagio.com/tour/.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Originally approved by the US FDA in January 2021 with a Supplemental PMA Approval for its latest device in June 2022, Seno Medical’s Imagio^® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

###

ⁱ Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoeconomics Outcomes Res 2018;10:157-167.

The category-defining Imagio^® Breast Imaging System helps physicians 
differentiate between benign and malignant breast lesions using a 
novel combination of ultrasound and opto-acoustic technology.

[SAN ANTONIO, TX – June 28, 2022] Seno Medical’s Imagio^® Breast Imaging System, a revolutionary new modality in breast imaging, has received supplemental premarket approval (PMA) from the Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA). Seno’s market-ready, groundbreaking diagnostic breast cancer imaging system helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic/ultrasound (OA/US) technology to provide information on breast lesions in real time, helping providers to characterize and differentiate masses that may — or may not — require more invasive diagnostic evaluation. 

The Imagio^® Breast Imaging System incorporates state-of-the-art ultrasound imaging technology required for premier breast imaging centers, as well as advanced ultrasound technology integrated into the opto-acoustic probe, a new ultrasound probe, and elimination of redundant electronics, making this version of Imagio^® more ergonomic and truly disruptive for the marketplace with the latest technological advances.

Tom Umbel, President and CEO of Seno Medical, commented, “This team is passionately committed to providing a revolutionary leap forward in patient care, and our commercial version of our Imagio^® System delivers just that. With our novel OA/US platform, combined with the latest technologies available today in breast imaging, we are delivering a new hybrid modality that will help providers deliver the best care possible to their patients.”

The company is launching a mobile education and demonstration tour, Imagio^® OA/US Road Show - Scans Across America, to enable on-site, hands-on demonstration with the Imagio^® System throughout the United States. The Imagio^® OA/US Road Show - Scans Across America tour will begin in late July with continued stops across the country throughout 2022. 

Breast biopsy procedures, caused by false-positive diagnostic assessments, cost the US healthcare system more than $2 billion per year.ⁱ Seno’s Imagio^® technology could significantly reduce those costs with its non-invasive OA/US innovation.

Seno’s OA/US system combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer — angiogenesis and hypoxia — Seno Medical has shown that the Imagio^® OA/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio^® System, Seno includes an artificial intelligence (AI) decision-support tool (SenoGram^®) to aid physicians in interpreting the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging.

The system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Originally approved by the US FDA in January 2021, Seno Medical’s Imagio^® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

###

ⁱ Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoeconomics Outcomes Res 2018;10:157-167.

[SAN ANTONIO, TX – April 25, 2022] Seno Medical’s Imagio ^® Breast Imaging System has been selected by the Edison Awards program as a GOLD award winner in the Science & Medical category. The award was presented at the program’s annual gala on April 21, 2022.

The Edison Award’s Gold, Silver and Bronze Winners are chosen as the "best of the best" within their respective categories by some of the world's top senior business executives, designers, academics, and innovation leaders. Being recognized with an Edison Award is one of the highest accolades a company can receive in the name of innovation and business success. The Edison Awards honor excellence in new product and service development, marketing, human-centered design, and innovation.  A full list of winners can be found here.

“We are simply elated to be honored with an Edison award,” Tom Umbel, Seno’s Chief Executive Officer, commented. “This recognition for our Imagio® technology truly validates all the work that the team at Seno has passionately persevered toward to improve the patient and provider experience.”

Breast biopsy procedures caused by false-positive diagnostic assessments in the United States cost the healthcare system more than $2 billion per year.ⁱ Seno’s Imagio® technology could reduce those costs with its non-invasive OA/US technology to help physicians better differentiate between benign and malignant breast lesions in real time, helping providers characterize and differentiate masses that may—or may not—require more invasive diagnostic evaluation.

The company’s OA/US technology combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and hypoxia – Seno Medical has shown that the Imagio® OA/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared to traditional diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio® System, Seno includes an artificial intelligence (AI) decision-support tool (the SenoGram®) to aid physicians in interpreting the new images that, along with training and certification, helps radiologists make the transition from ultrasound alone to OA/US imaging.

The system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Approved by the US FDA in January 2021, Seno Medical’s Imagio^®  Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

###

[i] Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoeconomics Outcomes Res 2018;10:157-167.

[SAN ANTONIO, TX – April 8, 2022] The 2022 Medical Device Excellence Awards program has selected Seno Medical’s Imagio^® Breast Imaging System as a GOLD award winner in the Radiological, Imaging, and Electromechanical Devices category.

The Medical Design Excellence Awards (MDEA) is the premier awards program for the medtech industry. Since its inception in 1998, the mission of the MDEAs has been to recognize significant achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility.

“These medtech innovations demonstrate excellence in design & engineering as well as improve healthcare delivery & accessibility,” according to the MDEA media partner, MD+DI.

“What an incredible honor to be recognized as a GOLD award winner by MDEA for our innovation,” Tom Umbel, Seno’s Chief Executive Officer, commented. “The entire team at Seno Medical has worked tirelessly to improve patient care through the use of Imagio, and we are proud to be in the company of all of these groundbreaking award winners.”

Breast biopsy procedures caused by false-positive diagnostic assessments in the United States cost the healthcare system more than $2 billion per year.ⁱ Seno’s Imagio^® technology could reduce those costs with its non-invasive OA/US technology to help physicians better differentiate between benign and malignant breast lesions in real time, helping providers characterize and differentiate masses that may—or may not—require more invasive diagnostic evaluation.

The company’s OA/US technology combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and hypoxia – Seno Medical has shown that the Imagio^® OA/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared to traditional diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio^® System, Seno includes an artificial intelligence (AI) decision-support tool (the SenoGram^®) to aid physicians in interpreting the new images that, along with training and certification, helps radiologists make the transition from ultrasound alone to OA/US imaging.

The system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Approved by the US FDA in January 2021, Seno Medical’s Imagio^® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

###

[i] Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoeconomics Outcomes Res 2018;10:157-167.