This company is close to getting FDA approval for its brain chip

Paradromics is one step closer to obtaining US Food and Drug Administration approval for commercial approval of its brain chip, which will treat paralyzed patients and restore their ability to communicate.

It comes after its fast-growing team of nearly 50 scientists and engineers at the neurotech startup caught the attention of federal regulators.

Paradomix, founded in 2015, is developing a brain chip that could help severely paralyzed patients regain their ability to communicate by decoding their neural signals. Today, Thursday, the Austin, Texas-based company announced that it had received a designation for its innovative device under the FDA’s “Breakthrough Device designation” program, which precedes emergency use approval for vaccines and medicines.

The company called its device “Connexus Direct Data Interface”.

CEO Matt Angel said the latest approval, along with $33 million in funding, will help Paradomix bring its devices to market.

Paradomix is ​​part of the emerging brain-computer interface industry, or BCI, a system that decodes brain signals and translates them into commands for external devices. Experts believe the systems could one day help treat diseases such as blindness and mental illness.

Perhaps the most well-known name in the industry is Neuralink, thanks to the high profile of its co-founder Elon Musk, who is also the CEO of Tesla, SpaceX and Twitter.

Scientists have been studying BCI technology for decades, and several companies have developed promising systems that they hope to bring to market. But getting Food and Drug Administration (FDA) approval for a commercial medical device is no small task — it requires companies to conduct several very thorough rounds of testing and successfully collect safety data, according to CNBC, which was viewed by Al

As of May, none of the BCI companies had been able to extract the final seal of approval from the Food and Drug Administration.

It is noteworthy that the “Paradomix” device works as an assistive communication device that translates nerve signals into text or complex speech. An array of small electrodes is implanted directly into brain tissue, where they measure and decode brain signals that are eventually emitted to external devices through a transceiver located under the skin in the chest.

Angel said his company’s BCI is designed to last about 10 years and will initially be used to help patients who have lost their ability to communicate physically. The device would require invasive brain surgery, but Angel said the quality of nerve signals that could be measured would allow patients to communicate at a faster, more natural rate than non-invasive BCI devices such as those developed by rival Synchron.

The US Food and Drug Administration has granted 32 such designations in fiscal year 2023 so far, according to its website.

Angel said the appointment would help create a “fast track” of communication between the administration and Paradomics, a feature that could be key to getting regulators to approve future clinical trials faster.

The company is currently conducting animal safety trials, and the data from those trials will help the FDA decide whether to approve a human study. Angel said Paradomix hopes to launch its first clinical trial with human patients in the first half of 2024.

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