Paradromics has received the Breakthrough Device designation from the FDA
Scientists have been studying BCI technology for decades, and several companies have developed promising systems that they hope to bring to market. But receiving FDA approval for a commercial medical device is no small task — it requires companies to successfully conduct several extremely thorough rounds of testing and data safety collection.
"It's essentially taking some of the things that have been successful in previous clinical trials, and then improving on them from an engineering standpoint to make them better," Angle told CNBC in an interview.Angle said the company's BCI is designed to last around 10 years and will initially be used to help patients who have lost their ability to physically communicate.
The company is currently conducting animal safety trials, and the data from those trials will help the FDA determine whether to approve an in-human study. Angle said Paradromics is hoping to launch its first clinical trial with human patients in the first half of 2024."It's a beautiful story," Prime Movers Lab founder and general partner Dakin Sloss told CNBC in an interview. "And it's a real technology that's working now, today.
Angle said it is an exciting time in the BCI field, especially as multiple companies are working to distinguish themselves in an industry that he estimates will create billions of dollars in value. But while it is easy to get excited about the future capabilities of BCIs, Angle believes a lot of good can already be done.
"A lot of people are excited about the futuristic, kind of speculative applications. But the reality of brain-computer interfaces is, in some ways, more exciting," he said. "It can transform what would otherwise be really challenging problems in brain health."
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