Brain implant Paradromics launches patient registration | Wilnesh News

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The Fourth of July week kicked off with some announcements in the neurotech space.

Brain implant startup Paradromics is taking steps to prepare for its first human trials next year, announcing on Monday that it has launched its official patient registry.

Paradromics, founded in 2015, is building a brain-computer interface (BCI) called Connexus Direct Data Interface. BCI is a system that deciphers brain signals and converts them into external technological commands.

Paradromics’ system will initially be used as an assistive communication device, converting brain signals into output such as text or synthesized speech. This means severely paralyzed patients could eventually use it to restore their ability to communicate.

Academics have been researching brain-computer interfaces for decades, and several other companies, including Elon Musk’s Neuralink, have been developing their own systems. The companies vary in design and ambition, but the industry has heated up in recent years thanks to investments from high-profile backers such as Musk, Microsoft co-founder Bill Gates and Amazon founder Jeff Bezos.

Gates and Bezos’ investment firms provided financing for a BCI company called Synchron.

Paradromics’ BCI is designed to insert directly into brain tissue, which means patients who want one will have to undergo major surgery. While surgery always comes with risks, CEO Matt Angle told CNBC last year that the quality of neural signals that Paradromics can measure will allow patients to communicate at a faster, more natural pace than less invasive brain-computer interfaces.

The company still needs to undergo rigorous testing by the U.S. Food and Drug Administration before its technology can be commercialized. It aims to conduct first-in-human trials in 2025, and patients can express interest in participating through Paradromics’ new registry.

Paradromics also announced that it has received FDA approval Product life cycle consulting planor TAP, Monday.

TAP is designed to help expedite communications between the FDA and companies that have received the agency’s Breakthrough Device designation, which is awarded to medical devices that have the potential to provide improved treatments for debilitating or life-threatening diseases. Paradromics has received Breakthrough Device designation twice, according to Paradromics A release.

The FDA can be slow to respond or difficult to contact because it often works with thousands of organizations at once. Therefore, Paradromics’ establishment of open lines of communication through TAP will help the company and the agency stay on the same page.

“We want to provide the best equipment possible in the safest possible time, so we are pleased to be participating in the TAP program,” Angle said in the release.

Please feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.

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