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.