“I think it’s going to blow your minds,” Musk said. “It’s like a Fitbit in your skull with tiny wires.”I’m excited to announce that we received a breakthrough device designation from the FDA in July.” Elon Musk reports.”I want to be clear, “We’re working closely with the FDA. We’ll be extremely rigorous. We’ll significantly exceed the FDA guidelines for safety. We will make this as safe as possible.”