Press Releases

[SAN ANTONIO, TX – SEPTEMBER 14, 2023] Seno Medical Instruments, Inc., the leader in improving the process of diagnosing breast cancer and the pioneer of the Imagio^® Breast Imaging System with opto-acoustic/ultrasound (OA/US) imaging technology, has added Agnes Berzsenyi to its Board of Directors, effective immediately. 

Ms Berzsenyi spent over 27 years at General Electric, where she held prominent leadership positions driving disruptive innovation, global growth and profitability. In her most recent role, Ms Berzsenyi was the President and CEO, Women's Health & X-ray, for GE Healthcare. In this role, she was responsible for driving the global strategic and commercial direction for the Women's Health & X-ray portfolios inclusive of mammography, bone densitometry, X-ray and services.  Her responsibilities included product innovation, commercial growth, and customer collaboration to reshape the mammography experience for women all around the world with innovative products such as Senographe Pristina, SenoBight HD (Contrast-enhanced mammography) and Pristina Dueta, the industry's first wireless remote that allows women to manage their own compression during their mammogram. 

“Agnes brings passion with a deep and vast background in Women's Health to her new role on Seno Medical's Board.  Her time spent at GE Healthcare as a senior executive leading the company's efforts in Women's Imaging will be invaluable to our company.” said Tom Umbel, CEO of Seno Medical. “We welcome Agnes and look forward to her contributions to the future of Seno Medical.”

Commenting on her appointment, Ms. Berzsenyi said, “I am very excited about the possibilities of what OA/US imaging can do to improve breast cancer diagnosis. I was extremely impressed when I saw clinical results and heard feedback from several recognized expert clinicians. The Seno team is clearly very passionate about the realization of this innovative breakthrough technology and its ability to improve the care for so many affected by the risk of cancer – as many close to me have been impacted.”

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. Approved by the US FDA in January 2021 with additional approval in June 2022 including its state-of-the-art ultrasound technologies, 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. 

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Seno’s Imagio^® System Uses Photoacoustic (Opto-acoustic) and Ultrasound Imaging to help doctors better characterize suspicious breast lesions to avoid unnecessary invasive biopsies and improve patient care.

[San Antonio, TX – July 20, 2023] Seno Medical’s technology platform for the Imagio^® Breast Imaging System - which includes Photoacoustic imaging - has been added to the Digital Imaging and Communications in Medicine (DICOM^®) Standards update version 2023c (Supp 229). The DICOM Standard is managed by the Medical Imaging & Technology Alliance - a division of the National Electrical Manufacturers Association.

This inclusion in the internationally-accepted standards enables photoacoustic images to be accepted as part of a best practice standard for medical imaging providers.

Imagio^® opto-acoustic/ultrasound (OA/US) technology combines laser optics (photoacoustic imaging) and grayscale ultrasound to offer 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 deoxygenation — the Imagio^® OA/US Breast Imaging System is 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 ionizing radiation (x-rays) or contrast agents. 

DICOM^® — Digital Imaging and Communications in Medicine — is the international standard for medical images and related information. It defines the formats for medical images that can be exchanged with the data and quality necessary for clinical use. DICOM^® is implemented in almost every radiology, cardiology imaging, and radiotherapy device (X-ray, CT, MRI, ultrasound, etc.), and increasingly in devices in other medical domains such as ophthalmology and dentistry. With hundreds of thousands of medical imaging devices in use, DICOM^® is one of the most widely deployed healthcare messaging Standards in the world. 

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. Approved by the US FDA in January 2021 with additional approval in June 2022 including its state-of-the-art ultrasound technologies, 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. 

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[SAN ANTONIO, TX – March 23, 2023] The Artificial Intelligence Excellence Awards program has selected Seno Medical’s AI platform, SenoGram^® — exclusively available in conjunction with the company’s Imagio^® Breast Imaging System — as a winner in its first annual program. SenoGram^® is an artificial intelligence (AI) decision-support tool that helps physicians interpret new images from the Imagio^® System.  The SenoGram^®, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging to more accurately determine the likelihood of malignancy of breast lesions.

The Artificial Intelligence Excellence Awards recognizes those organizations, products, and people who bring AI to life and apply it to solve real problems. Awards are broken down by categories; the SenoGram^® AI decision-support tool was recognized in the Diagnosis category. 

“We are delighted to be included among these groundbreaking leaders in the artificial intelligence stratosphere,” Tom Umbel, Seno’s Chief Executive Officer, commented. “The use of the SenoGram^® is a tremendous benefit to clinicians in interpreting the images from Imagio^®. Our AI advancements improve outcomes for patients and increase diagnostic confidence of providers.”

“We are so proud to name Seno Medical as a winner in our inaugural Artificial Intelligence Excellence Awards program”, said Maria Jimenez, Chief Nominations Officer for Business Intelligence Group. “It was clear to our judges that Seno was using AI to improve the lives of their customers and employees. Congratulations to the entire team!”

Recently honored with a Gold Edison award, a Gold Medical Design Excellence Award and as a semifinalist in the 2022 Minnies for its medical innovation, Seno’s pioneering 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 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 Imagio^® System was cleared by the US FDA in 2021 and received Supplemental PMA Approval for its market-ready device in June 2022. 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.

About Business Intelligence Group www.bintelligence.com
The Business Intelligence Group was founded with the mission of recognizing true talent and superior performance in the business world. Unlike other industry award programs, these programs are judged by business executives having experience and knowledge. The organization’s proprietary and unique scoring system selectively measures performance across multiple business domains and then rewards those companies whose achievements stand above those of their peers.

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.

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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 – January 13, 2023) Seno Medical has entered into an exclusive distributor agreement with Genetik, Inc., to market, sell and service the company’s groundbreaking Imagio^® Opto-Acoustic/Ultrasound (OA/US) Breast Imaging System. This distributor agreement – a first for Seno – will enable Genetik to regionally distribute the Imagio^® System in Singapore, where the distributor is headquartered.

“We are thrilled to be partnering with a reputable organization such as Genetik to stimulate commercial adoption of the Imagio^® System into Southeast Asia,” commented Tom Umbel, CEO and President of Seno Medical. “This agreement represents a major milestone for Seno Medical and the continued acceptance and adoption of our new fusion modality in breast imaging.”

“We are proud to work with innovative and highly accurate technologies that can change the standard of care for patients. We look forward to representing this state-of-the-art product for diagnosing breast cancer – the only global FDA-approved technology based on photoacoustic fused with ultrasound,” commented Genetik CEO V. B. Balrai Singh.

Recently honored with a Gold Edison award, a Gold Medical Design Excellence Award and as a semi-finalist in the 2022 Minnie’s 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 Imagio^® System was cleared by the US FDA in 2021 and received a supplemental PMA approval for its market-ready device in June 2022. 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.

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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.
 

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.

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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.

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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