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Artificial Retina Receives FDA Approval |
Posted on: 2/14/2013 12:00:00 AM... The U.S. Food and Drug Administration (FDA) granted market approval to an artificial retina technology on February 14, the first bionic eye to be approved for patients in the United States.
The device, called the Argus® II Retinal Prosthesis System, transmits images from a small, eye-glass-mounted camera wirelessly to a microelectrode array implanted on a patient's damaged retina. The array sends electrical signals via the optic nerve, and the brain interprets a visual image.
The Argus II is manufactured and will be distributed by Second Sight Medical Products of Sylmar, California, which is comprised of scientists and engineers from the academic, federal, and private sectors who spent nearly two decades developing the system with public and private investment.
According to a National Science Foundation (NSF) statement, the research efforts leading to the Argus II have bridged cellular biology and microelectronics, which led to a miniaturized, low-power integrated chip for performing signal conversion, conditioning, and stimulation functions. The hardware was paired with software processing and tuning algorithms that convert visual imagery to stimulation signals, and the entire system had to be incorporated within hermetically sealed packaging that allowed the electronics to operate in the vitreous fluid of the eye indefinitely. The research team also had to develop new surgical techniques in order to integrate the device with the body, ensuring accurate placement of the stimulation electrodes on the retina.
The NSF statement specifically noted, "The artificial retina provides an interface between biotic and abiotic systems. Its unique design characteristics rely on system-level optimization, rather than the more common practice of component optimization, to achieve miniaturization and integration. Using the most advanced semiconductor technology, the engine for the artificial retina is a 'system on a chip' of mixed voltages and mixed analog-digital design, which provides self-contained power and data management and other functionality. This design for the artificial retina facilitates both surgical procedures and regulatory compliance."
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