Acceptance into the TAP program comes on the heels of FDA breakthrough device designation for the ARC-BCI system last month. Breakthrough device designation is a requirement for TAP consideration, according to a news release. Onward says that this nod made its BCI only the second such system accepted into the program.
TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Onward can benefit from more timely premarket interactions, earlier identification and mitigation of device development risk and a more efficient premarket review for its ARC-BCI system.
ARC-BCI uses brain-computer interface (BCI) technology in conjunction with ARC-IM neurostimulation. It aims to restore thought-driven lower limb mobility after spinal cord injury (SCI).
The BCI system uses AI to decode brain signals and translate them into specific instructions for the neurostimulation system. This converts the instructions into precise spinal cord stimulation, creating a “digital bridge” that restores communication between the brain and the body. Onward says the system can deliver thought-driven movement after paralysis.
“We are honored to be one of the first BCI companies included in this important program, which allows for the fastest FDA review times of new medical technology,” said Onward Medical CEO Dave Marver. “TAP enables us to reduce the time and cost to deliver the benefits of ARC-BCI to people living with paralysis.”
