The Center for Devices and Radiological Health of the U.S. FDA has granted Texas-based Seno Medical Instruments, Inc. premarket approval (PMA) for its diagnostic breast cancer imaging technology that helps physicians differentiate between benign and malignant breast lesions.
Specifically, the company’s Imagio Breast Imaging System uses noninvasive opto-acoustic ultrasound (OA/US) technology to provide information on suspicious breast lesions in real time, helping providers characterize and differentiate masses that may—or may not—require more invasive diagnostic evaluation.
Moreover, Seno’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 deoxygenation—Seno Medical has shown that the Imagio OA/US Breast Imaging system will be an effective tool to help radiologists confirm or rule out malignancy compared to traditional diagnostic imaging modalities—without exposing patients to potentially harmful ionizing radiation or contrast agents.
Seno includes an AI physician decision support tool, the SenoGram, to aid in interpreting the new images that, along with training and certification, help 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’s CEO Tom Umbel comments, “We are thrilled to have reached this milestone and are looking forward to moving our technology platform forward in the U.S. with this FDA approval. Our internal team and our faithful investigators and clinical trial sites have worked diligently to bring Imagioto market and improve care for patients and providers with the precise diagnostic capabilities and enhanced decision-making support that our novel OA/US imaging provides.”
Image: Seno Medical’s Imagio Breast Imaging System uses non-invasive opto-acoustic ultrasound technology to provide information on suspicious breast lesions in real time, helping providers characterize and differentiate masses that may—or may not—require more invasive diagnostic evaluation.
