Michael Barbella, Managing Editor02.08.23
Seno Medical Instruments Inc. has released its Imagio Breast Imaging System to the market and is ensuring its uptake among healthcare professionals by embarking on a road show.
The company's mobile education and demonstration tour, Imagio OA/US Road Show - Scans Across America, provides clinicians with hands-on demonstrations of its diagnostic breast imaging system, which helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic/ultrasound (OA/US) technology. Providing information about breast lesions in real time, Imagio aims to enable healthcare providers to characterize masses that may or may not require more invasive diagnostic evaluation.
The market-ready Imagio System received supplemental premarket approval (PMA) from the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last summer. It features advanced ultrasound technology integrated into a new ultrasound probe (opto-acoustic probe), and eliminates redundant electronics.
"The time has come for the market to start adopting and using this groundbreaking new hybrid modality for breast imaging," Seno Medical President/CEO Tom Umbel said.
Breast biopsy procedures, caused by false-positive diagnostic assessments, cost the U.S. 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 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. The system does not expose 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.
Seno Medical is a San Antonio, Texas-based medical imaging company developing and commercializing opto-acoustic imaging. Originally approved by the 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.
Reference
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
The company's mobile education and demonstration tour, Imagio OA/US Road Show - Scans Across America, provides clinicians with hands-on demonstrations of its diagnostic breast imaging system, which helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic/ultrasound (OA/US) technology. Providing information about breast lesions in real time, Imagio aims to enable healthcare providers to characterize masses that may or may not require more invasive diagnostic evaluation.
The market-ready Imagio System received supplemental premarket approval (PMA) from the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last summer. It features advanced ultrasound technology integrated into a new ultrasound probe (opto-acoustic probe), and eliminates redundant electronics.
"The time has come for the market to start adopting and using this groundbreaking new hybrid modality for breast imaging," Seno Medical President/CEO Tom Umbel said.
Breast biopsy procedures, caused by false-positive diagnostic assessments, cost the U.S. 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 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. The system does not expose 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.
Seno Medical is a San Antonio, Texas-based medical imaging company developing and commercializing opto-acoustic imaging. Originally approved by the 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.
Reference
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