The Revolutionizing Prosthetics program was chosen as the first test case under the FDA Innovation Pathway program to “facilitate the development and regulatory evaluation of innovative medical devices.”
We have received investigational device exemptions from the FDA and local institutional review board approvals to be able to use the Modular Prosthetic Limb (MPL) as an upper-limb prosthesis for amputees and tetraplegic subjects. The MPL has been controlled through a variety of source signals (e.g., myoelectric electrodes as well as implantable cortical arrays).
Medical Device Innovation Initiative White Paper: CDRH Innovation Initiative (FDA Center for Devices and Radiological Health, February 2011)
FDA's Medical Device Innovation Initiative (FDA, February 8, 2011)
2013: FDA approves implantation of microelectrode arrays in somatosensory (S1) cortex for recording and imparting electrical stimulation
4-17-13: First human is implanted with two microelectrode arrays in parietal cortex (AIP and BA5), with no device-related adverse events to date
2-10-11: First human is implanted with two microelectrode arrays in primary motor cortex (M1) hand area, with no device-related adverse events to date