11.13.14
The U.S. Food and Drug Administration (FDA) recently emphasized its push to empower the medical device industry in studying and developing new technologies to treat patients with disabilities.
In a blog post, William Maisel, the FDA’s deputy center director for science and chief scientist for the Center for Devices and Radiological Health (CDRH), said the agency is committed to encouraging innovation to benefit patients.
Examples of devices that recently cleared the FDA’s premarket requirements, according to the blog post, include:
As an example, he pointed to the summer approval for a robotic exoskeleton device that offers “powered hip and knee motion to enable individuals with spinal cord injury to stand upright and walk.”
In a blog post, William Maisel, the FDA’s deputy center director for science and chief scientist for the Center for Devices and Radiological Health (CDRH), said the agency is committed to encouraging innovation to benefit patients.
Examples of devices that recently cleared the FDA’s premarket requirements, according to the blog post, include:
- The DEKA Arm System, a prosthetic arm that can perform multiple, simultaneous, powered movements controlled by electrical signals from electromyogram electrodes;
- The Nucleus Hybrid L24 Cochlear Implant System, which can help people 18 years of age and older —who don’t benefit from conventional hearing aids—with a specific kind of hearing loss; and
- The Argus II Retinal Prosthesis System, a device to treat adult patients with vision loss from advanced retinitis pigmentosa.
As an example, he pointed to the summer approval for a robotic exoskeleton device that offers “powered hip and knee motion to enable individuals with spinal cord injury to stand upright and walk.”