United States: In a recent announcement on the fourth of July, Paradromics, a startup for brain implants, plans to conduct its first-in-human trial next year.
The company started with an announcement and its official patient registry launch.
More about Paradromics
A company, founded in 2015 is building a brain-computer interface (BCI) called the Connexus Direct Data Interface. A BCI deciphers brain signals and then translates them into commands that can be understood by external devices.
Its utilization could be envisioned for patients suffering from a severe form of paralysis, where the device would help them to communicate with the world.
The work on BCIs has been going on for more than a decade now, where other competing companies, such as Neuralink of Elon Musk, have also been developing their own versions of similar devices, as CNBC reported.
The design of Paradromics’ BCI is so that it can be directly inserted into the brain tissues of the patient through a major surgery.
According to the CEO Matt Angle, in its statement last year, said that the procedure for the device would come with risks; however, the quality of the neural signals Paradromics would allow patients to communicate at a much faster and almost natural rate.
Rigorous testing Required – FDA
According to the US Food and Drug Administration (FDA), the company needs to undergo intensive testing for its technology before it can make its device available commercially.
The company is planning to have its first-in-human trial next year, where patients will be able to show interest in participation directly through Paradromics’ new registry, as CNBC reported.
Moreover, Paradromics has also announced that it had been accepted to the FDA’s Total Product Life Cycle Advisory Program, or TAP, recently, which could help to fasten the communication between the FDA and companies, those who have already gotten the agency’s Breakthrough Device designation.