breakthrough device designation
The company's brain-computer interface uses direct cortical electrical stimulation to help with motor recovery in people with chronic stroke-related impairments.
The FDA clarifies its interpretation of "more effective," and indicates it will consider improved accessibility of a device during the Breakthrough designation process.
When determining approval for Breakthrough Device designation, the FDA will consider whether the device addresses present health inequities.
The company will use the funding to support the commercial expansion of its product.