Seno Medical Instruments has secured premarket approval (PMA) from the Centre for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA) for its diagnostic breast cancer imaging technology.
The Imagio breast imaging system has been developed to enable physicians better differentiate between benign and malignant breast lesions.
Seno Medical’s breast imaging system uses non-invasive opto-acoustic ultrasound (OA/US) technology to deliver information on suspicious breast lesions in real-time. It will help providers characterize and differentiate masses that may or may not need more invasive diagnostic assessment.
The firm’s OA/US technology unites laser optics and grayscale ultrasound to deliver fused functional and anatomical breast imaging.
The opto-acoustic images offer a unique blood map in and around breast masses, while the ultrasound delivers a traditional anatomical image.
Seno Medical stated that it has demonstrated that the Imagio OA/US breast imaging system is an effective tool for radiologists to confirm or rule out malignancy compared to traditional diagnostic imaging modalities through the appearance or absence of two hallmark indicators of cancer such as angiogenesis and deoxygenation.
The company also offers an AI physician decision support tool called SenoGram to help integrate the new images, thereby helping radiologists to easily shift from an ultrasound alone to OA/US Imaging.
Seno’s system is designated for use by trained and qualified healthcare providers to assess palpable and non-palpable breast abnormalities in adult patients who are specified for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.
Seno Medical CEO Tom Umbel said: “We are thrilled to have reached this milestone and are looking forward to moving our technology platform forward in the US with this FDA approval.
“Our internal team and our faithful investigators and clinical trial sites have worked diligently to bring Imagio to 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.”
In October 2020, GE Healthcare introduced a contrast-enhanced guided biopsy solution Serena Bright in the US, to help improve breast cancer outcomes for women.
