The pathway of approval for sale and use of Seno’s opto-acoustic imaging system is governed by the Food and Drug Administration (FDA) Center for Devices and Radiological Health. The FDA’s Office of Device Evaluation is responsible for ensuring the safety and effectiveness of the medical devices available to U.S. consumers and does so based on documentation collected by the device manufacturer. Although optical and ultrasound devices are both already used clinically, the unique combination of technologies present in Seno’s opto-acoustic tomography system will require a regulatory approval process reserved for new technologies, which is known as a Pre-Market Approval.
4. What is the pathway for regulatory approval?