US-based medical imaging company Seno Medical and Genetik have signed an exclusive distributor agreement for the former’s Imagio Opto-Acoustic/Ultrasound (OA/US) Breast Imaging System.
Under the terms of the agreement, Genetik will market, sell and service the imaging system in Singapore.
Imagio uses non-invasive OA/US technology to differentiate between benign and malignant breast lesions in real time.
This helps healthcare providers characterise masses that may or may not require more invasive diagnostic assessment.
Combining laser optics and grayscale ultrasound, the OA/US system provides fused functional, morphological and anatomical breast imaging.
The system uses the opto-acoustics to provide a blood map in and around breast masses.
The system is indicated for adult patients requiring assessment of palpable and non-palpable breast abnormalities.
Patients are referred for a diagnostic imaging breast work-up after clinical presentation or screening mammography.
Seno Medical CEO and president Tom Umbel said: “We are thrilled to be partnering with a reputable organisation such as Genetik to stimulate commercial adoption of the Imagio System into Southeast Asia.
“This agreement represents a major milestone for Seno Medical and the continued acceptance and adoption of our new fusion modality in breast imaging.”
Seno also includes SenoGram, an artificial intelligence (AI) decision-support tool that is designed to help healthcare providers interpret the new images.
In addition to training and certification, the AI tool helps radiologists transition from ultrasound alone to the OA/US imaging, which more precisely assigns malignancy likelihood.
Last June, the Imagio System received a supplemental premarket approval (PMA) from the US Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH).