Elon Musk’s Neuralink Struggles to Get Approval for Testing its Device on Humans

Despite FDA rejection last month, the company continues to seek collaborations for trials.
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Neuralink, Elon Musk’s brain implant firm, has approached one of the largest neurosurgery centers for a potential clinical trial partnership. According to a Reuters report, the move comes as Neuralink prepares to test its devices on humans, pending regulatory approval. Despite reports earlier this month that the FDA rejected Neuralink’s request to begin clinical trials in early 2022, the company is forging ahead with plans for human testing of its brain-computer interface (BCI) device.

The BCI device uses electrodes to provide direct communication to computers by penetrating or sitting on the surface of the brain. Until now, no company has received US approval to bring a BCI implant to market. Neuralink began developing brain implants in 2016 with the aim of curing intractable conditions like paralysis and blindness. Musk has expressed hope that Neuralink’s brain implants will become as widespread as Lasik eye surgery.

The Barrow Neurological Institute, a Phoenix-based neurological disease treatment and research organization, is reportedly among the institutions that Neuralink has been in talks with to carry out human trials. The discussions do not guarantee a collaboration, however. The Musk led company is also reportedly discussing partnership with other institutions.

Barrow specializes in the use of deep brain stimulation (DBS) devices, which have been approved by the FDA since 1997 to mitigate tremors in Parkinson’s disease patients. Over 175,000 patients have received these implants. In contrast, Neuralink’s brain implants use electrodes to provide direct communication to computers and are still awaiting regulatory approval for human use.

The move comes as Neuralink faces two federal probes into its practices. The US Department of Agriculture’s Inspector General began investigating potential animal-welfare violations at Neuralink last year, and current and former employees have raised concerns about the company’s rushed animal experiments resulting in needless suffering and deaths

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Tasmia Ansari
Tasmia is a tech journalist at AIM, looking to bring a fresh perspective to emerging technologies and trends in data science, analytics, and artificial intelligence.

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