A 2022 Medical Design Excellence Awards finalist has won a supplemental PMA for a device to provide better detection of breast cancer.
Seno Medical has received a PMA for the Imagio Breast Imaging System, a device that differentiates between benign and malignant breast lesions using opto-acoustic/ultrasound (OA/US) technology.
“This was a big deal for us, and we were really excited,” Tom Umbel, president and CEO of Seno Medical, told MD+DI. “It’s been a long time coming working this through and getting everything squared away within the company and with FDA.”
The technology stands out because of the approach and method Seno is taking for breast cancer detection. It includes an artificial intelligence decision-support tool called the Seno Gram, to aid physicians in interpreting the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging.
“The Imagio Breast Imaging System provides information out there that no other system does. It’s a fusion of laser imaging – the opto side, the optoaccustics, with ultrasound,” Umbel said. “The ultrasound does what it normally does. It provides the anatomical information that radiologists, particularly breast imagers are familiar with. The laser gives us the ability to visualize the blood vessels in the breast as well, particularly those that are interfacing with the lesion or the area of interest. Then simultaneously with being able to visualize them, we can measure the oxygen content of those blood vessels.”
He added, “a deoxygenated vessel with vessels that are perpendicular to the lesion and clearly involved with the lesion are two strong indicators of a malignancy.”
Tammy Garcia, senior VP of Sales and Marketing for Seno Medical, gave further insight on how the technology stands out.
“What our technology does is use the body’s own hemoglobin as a natural contrast agent to provide that information, which again is giving the physician a lot more information to make a decision without the injections and without the contrast agents,” she told MD+DI.
Plans now call for the company to launch a mobile education and demonstration tour, Imagio OA/US Road Show - Scans Across America, to enable on-site, hands-on demonstration with the Imagio System throughout the U.S. The roadshow will start later this month.