Elon Musk’s Neuralink is in early talks to raise about $500 million at a pre-money valuation of $8.5 billion, a sharp rise from its $5 bill...

At least 11 employees working at the FDA's Center for Devices and Radiological Health - which oversees medical device reviews - have receiv...

A wave of federal job cuts initiated by the Department of Government Efficiency (DOGE) is impacting regulatory agencies investigating Elon ...

Neuralink has implanted its device in third human patient and plans more procedures in 2025. The device allows paralyzed individuals to con...

FDA inspectors identified the issues at Neuralink's animal testing facilities in California in June 2023, several weeks after the agency ha...

Neuralink, which first tested its device in monkeys and other animals, is now testing the device in humans. The company makes a brain-chip ...

The inspectors identified quality control lapses at the company's California animal research facility. A similar inspection at Neuralink's ...

Neuralink does not have to divulge even basic details about its trial, including the facility where patients are being implanted with the d...

The request for an inquiry came from Democratic House Reps. Earl Blumenauer of Oregon, Jim McGovern of Massachusetts, and Barbara Lee and T...

Four U.S. lawmakers, including Democratic House Reps. Earl Blumenauer, Jim McGovern, Barbara Lee, and Tony Cardenas, have called on the Sec...

Elon Musk's Neuralink has gained approval to begin its first human clinical trial for its brain-computer interface implant. Known as the "P...

Billionaire entrepreneur Elon Musk's brain-chip startup Neuralink said on Tuesday that it has received approval from an independent review ...

Last month, Neuralink said it received US Food and Drug Administration (FDA) clearance for its first-in-human clinical trial, a critical mi...

Elon Musk has expressed grand ambitions for Neuralink, saying its chip would allow healthy and disabled people alike to pop into neighborho...

With the FDA approval out of the way, Musk's Neuralink can now implant actual humans in their heads with Neuralink device.

Neuralink has been developing brain implants since 2016 it hopes will eventually be a cure for intractable conditions such as paralysis and...

A year after the rejection, Neuralink is still working through the agency’s concerns. Three staffers said they were skeptical the company c...