ONWARD® Medical Accepted to New US FDA TAP Program for Development of its ARC-BCI™ System
This acceptance follows ONWARD Medical’s announcement last week that its investigational ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration.
- This acceptance follows ONWARD Medical’s announcement last week that its investigational ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration.
- ONWARD Medical is only the second BCI company to be accepted into the program.
- TAP provides ONWARD Medical with early and frequent strategic engagement from the FDA, patients, providers, and payers to facilitate more rapid development and widespread patient access to safe, effective, high-quality medical devices of public health importance.
- “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.