What makes Seno’s technology different?
Seno's technology produces high-resolution images related to the performance of tissue; this class of imaging techniques is known as functional imaging. By comparison, technologies such as x-rays depend on anatomical imaging. In Seno’s technology, contrast is generated based on hemoglobin concentration and tissue oxygenation, both of which are different from surrounding tissue in cancerous conditions due to a mechanism of tumor formation called angiogenesis. Images are generated without using ionizing radiation (x-rays) or injection of contrast agents. No other imaging technique offers high-resolution images produced in this fashion.
When will a research device be ready?
Seno licensed this technology to a world market leader, VisualSonics of Toronto Canada.
When will a device which is usable for humans be ready?
A human usable opto-acoustic device must pass rigorous FDA standards. Seno is actively working toward commercialization of a device to be used as an adjunct with mammography. This system is expected to be available in 2012.
What is the pathway for regulatory approval?
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 FDAs Office of Device Evaluation is responsible for ensuring the safety and effectiveness of the medical devices available to US 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, known as a Pre-Market Approval.
Is the technology dangerous?
The light used by the opto-acoustic tomography system is not harmful to skin and is within acceptable guidelines for maximum permissible exposure. Similarly, induced temperature-rise and pressure-rise parameters are comparable to that seen in other medical technologies. Nevertheless, the FDA will need to judge both the safety and efficacy of
the system. No x-rays are used in the production of images.
Is this technology patented?
Seno's opto-acoustic imaging technology is protected by patents. Additionally, because of the nature of the science and engineering on which the technology is based, significant expertise resides within the Seno team.
Why hasn't someone already developed this?
Although elegant in its principles, opto-acoustic imaging relies upon advanced technology and engineering. For example, the lasers, electronics, and ultrasound components used are unique to this application. Materials and engineering difficulties prevented construction of opto-acoustic imaging technology until recently.
Isn't this just an optical or ultrasound technique?
Unlike standard optical or ultrasonic techniques, which stimulate and detect signals using the same type of energy, in this modality, tissue is illuminated by light which produces an acoustic signal detected at the tissue edge. This is a departure from current imaging methods.