Seno Medical’s Imagio® Breast Imaging System, a revolutionary new modality in breast imaging, has received supplemental premarket approval (PMA) from the Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA). Seno’s market-ready, 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 and differentiate masses that may — or may not — require more invasive diagnostic evaluation.
The Imagio® Breast Imaging System incorporates state-of-the-art ultrasound imaging technology required for premier breast imaging centers, as well as advanced ultrasound technology integrated into the opto-acoustic probe, a new ultrasound probe, and elimination of redundant electronics, making this version of Imagio® more ergonomic and truly disruptive for the marketplace with the latest technological advances.
A Premarket Approval (PMA) application is scientific, regulatory documentation to the FDA to demonstrate the safety and effectiveness of a Class III device. PMA is the FDA’s most stringent device marketing application. The applicant must receive FDA approval of its PMA application before marketing the device. PMA approval is based on a determination by the FDA that the application contains sufficient valid scientific evidence to ensure the device is safe and effective for its intended uses.
Read the full press release here.