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FDA clears Neuralink chip for 2nd human trial, company says wire issue fixed

May 20

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The U.S. Food and Drug Administration (FDA) gave Neuralink the green light to implant its brain chip in a second human patient. The decision came just one week after the Elon Musk-backed startup admitted many of the device’s wires disconnected from its first patient’s brain.

Neuralink made several changes to the device and how it is implanted to fix that issue before resubmitting its work to the FDA, according to The Wall Street Journal.

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The device allows an individual to control digital devices using brain signals. Neuralink designed the chip specifically to help quadriplegic people. More than 180,000 Americans are quadriplegic, which means their paralysis prevents them from using all four limbs. The chip promises to improve their quality of life.

The adjustments to the first chip include embedding the ultra-thin connector wires deeper into the brain’s motor cortex to enhance stability and function.

The changes address issues experienced by Nolan Arbaugh, the first chip recipient. The wires in his chip became detached and temporarily resulted in a loss of functionality. Neuralink reported it stabilized the remaining threads and updated the software to improve the chip’s capabilities.

Arbaugh can now control a laptop and is able to use it to play games and browse the internet. He participates in research sessions for upwards of eight hours per day, and frequently uses it for personal activities on the weekends. Data showed Arbaugh used the device for nearly 70 hours in a week, thanks to updates in the technology.

“The games I can play now are leaps and bounds better than previous ones,” Arbaugh said. “I’m beating my friends in games that as a quadriplegic I should not be beating them in.”

Neuralink said ongoing adjustments and user feedback are critical. The company hopes to implant the updated chip in 10 additional patients in 2024.

Neuralink is actively accepting applications and plans to expand trials to Canada and Great Britain. The company hopes to open applications for both of those counties in the coming days.

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[KARAH RUCKER]

LAST WEEK STRAIGHT ARROW NEWS REPORTED NEURALINK KNEW OF POTENTIAL ISSUES WITH THE WIRE THREADS IN ITS BRAIN CHIP IMPLANT AFTER SEVERAL WIRES DETACHED FROM THE BRAIN OF THE COMPANY’S FIRST HUMAN PATIENT.

THE DEVICE ALLOWS USERS TO CONTROL DIGITAL INTERFACES USING ONLY THEIR BRAIN SIGNALS.

NOW, AFTER ELON MUSK’S MADE SIGNIFICANT DESIGN MODIFICATIONS TO THE IMPLANT TO FIX THE DETACHMENT PROBLEM, THE FOOD AND DRUG ADMINISTRATION HAS GIVEN THE THUMBS UP FOR A SECOND HUMAN TRIAL FOR THE BRAIN CHIP TECHNOLOGY.

AN ESTIMATED 180-THOUSAND AMERICANS LIVE WITH QUADRIPLEGIA, AND EVERY YEAR ABOUT 18,000 MORE INDIVIDUALS SUFFER LIFE-ALTERING SPINAL CORD INJURIES. MUSK’S NEURALINK HAS DEVELOPED AN INNOVATIVE BRAIN CHIP IMPLANT THAT PROMISES TO ENHANCE THE QUALITY OF LIFE FOR THESE INDIVIDUALS. 

NEURALINK HAS MADE ADJUSTMENTS TO ITS EARLIER VERSION BY EMBEDDING THE CHIP’S ULTRA-THIN WIRES DEEPER INTO THE BRAIN’S MOTOR CORTEX TO ENHANCE STABILITY AND FUNCTIONALITY. THESE CHANGES ADDRESS THE ISSUES FACED BY NOLAND ARBAUGH, THE FIRST RECIPIENT, WHOSE IMPLANT’S WIRES DISLODGED AND LED TO A LOSS OF FUNCTIONALITY.

NEURALINK REPORTED STABILIZING THE REMAINING THREADS AND UPDATED THE SOFTWARE TO RESTORE AND EVEN IMPROVE THE CHIP’S CAPABILITIES.

THE NEURALINK DEVICE ENABLES ARBAUGH TO CONTROL HIS LAPTOP, BROWSE THE INTERNET, AND PLAY GAMES — ACTIVITIES PREVIOUSLY LIMITED DUE TO HIS QUADRIPLEGIC CONDITION. 

ACCORDING TO A NEURALINK BLOG POST, ARBAUGH PARTICIPATES IN RESEARCH SESSIONS FOR UP TO EIGHT HOURS PER DAY. ON WEEKENDS, HIS PERSONAL USE AND RECREATIONAL ACTIVITIES WITH THE DEVICE CAN EXCEED TEN HOURS PER DAY. RECENTLY, HE USED THE DEVICE FOR A TOTAL OF 69 HOURS IN ONE WEEK, INCLUDING 35 HOURS OF STRUCTURED SESSIONS AND AN ADDITIONAL 34 HOURS OF PERSONAL USE. HE CONTINUES TO BE AMAZED BY THE TECHNOLOGY.

[NOLAN ARBAUGH]

“The games I can play now are leaps and bounds better than previous ones. I’m beating my friends in games that as a quadriplegic I should not be beating them in.”

[KARAH RUCKER]

THE COMPANY SAYS ONGOING ADJUSTMENTS AND USER FEEDBACK ARE CRUCIAL AS THE COMPANY PREPARES TO INCLUDE 10 IMPLANTS IN THIS YEAR’S STUDY. OVER 1,000 QUADRIPLEGICS HAVE ALREADY REGISTERED FOR NEURALINK’S TRIALS. 

NEURALINK IS ACTIVELY ACCEPTING APPLICATIONS AND PLANS TO EXPAND TRIALS TO CANADA AND BRITAIN — THE COMPANY SAYS APPLICATIONS FOR THOSE COUNTRIES WILL BE OPEN IN THE COMING DAYS.

TO STAY UP TO DATE ON NEWS OF THE DAY — DOWNLOAD THE STRAIGHT ARROW NEWS APP OR VISIT US AT SAN DOT COM.

FOR STRAIGHT ARROW NEWS, I’M KARAH RUCKER.