Seno Medical, based in the US, 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.

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. Seno’s Imagio technology could significantly reduce those costs with its patient-centric OA/US innovation.

In addition to the novel imaging provided by the ImagioSystem, 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 pre-market 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.