"Our first production device will be much like an iPhone 1" -- Elon Musk.

It’s been six years since Tesla, SpaceX (and now Twitter) CEO Elon Musk co-founded brain-control interfaces (BCI) startup, Neuralink. It’s been three years since the company first demonstrated its “sewing machine-like” implantation robot, two years since the company stuck its technology into the heads of pigs — and just over 19 months since they did the same to primates, an effort that allegedly killed 15 out of 23 test subjects. After a month-long delay in October, Neuralink held its third “show and tell” event on Wednesday where CEO Elon Musk announced, "we think probably in about six months, we should be able to have a Neuralink installed in a human."

Neuralink has seen tumultuous times in the previous April 2021 status update: The company’s co-founder, Max Hodak, quietly quit just after that event, though he said was still a “huge cheerleader” for Neuralink’s success. That show of confidence was subsequently shattered this past August after Musk reportedly approached Neuralink’s main rival, Synchron, as an investment opportunity.

Earlier in February, Neuralink confirmed that monkeys had died during prototype testing of its BCI implants at the ​​University of California, Davis Primate Center but rejected accusations by the Physicians Committee for Responsible Medicine of animal cruelty. Musk responded indirectly to those charges on Wednesday.

"Before we would even think of putting a device in an animal, we do everything possible we with rigorous benchtop testing, We're not cavalier about putting these devices into animals," he said. "We're extremely careful and we always want the device, whenever we do the implant — whether into a sheep, pig or monkey — to be confirmatory, not exploratory."

In July, Synchron beat Neuralink to market when doctors at Mount Sinai Hospital in New York successfully installed the company's inch-and-a-half long device into a person living with ALS. The patient, who has lost their ability to move and communicated independently, should be able to surf the web and send text messages using the device to translate their thoughts into computer commands. That same month, an affair Musk had with a Neuralink executive, who is now pregnant with his twins, also came to light.

Neuralink is still working towards gaining FDA approval for its implant, though the company was awarded the agency's Breakthrough Device Designation in July 2020. This program allows patients and caregivers more "timely access" to promising treatments and medical devices by fast tracking their development and regulatory testing. As of September, 2022 the FDA has granted that designation to 728 medical devices.

The FDA has also updated its best practices guidance regarding clinical and nonclinical BCI testing in 2021. "The field of implanted BCI devices is progressing rapidly from fundamental neuroscience discoveries to translational applications and market access," the agency asserted in its May guidance. "Implanted BCI devices have the potential to bring benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life."

Source:
courtesy of ENGADGET

by Andrew Tarantola

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