The race to commercialise brain-computer interfaces (BCIs) is intensifying. Synchron, a New York-based startup, has received FDA priority review for its Stentrode device. This puts it ahead of Elon Musk's Neuralink in the regulatory queue. Eleanor Rigby reports.

Synchron's device is a stent-like implant that sits inside a blood vessel in the brain. It is delivered via a minimally invasive procedure through the jugular vein. No open brain surgery is required. The FDA’s priority review designation means it will fast-track the application, potentially approving the device for market within months.

“We are thrilled by the FDA’s decision,” said Dr. Thomas Oxley, CEO of Synchron. “This brings us one step closer to helping people with paralysis control digital devices using their thoughts alone.”

Synchron’s approach is radically different from Neuralink’s. Musk’s company requires a craniectomy and robotic insertion of flexible threads into brain tissue. While Neuralink has shown impressive results in animals, it has yet to begin human trials. Synchron already has human data: the Stentrode has been implanted in four patients in Australia and one in the US, all with severe paralysis.

“Synchron’s design is elegant and safe,” said Dr. Leigh Hochberg, a neurologist at Brown University who consults for the company. “By using the brain’s vasculature, they avoid damaging neural tissue. This could be a game-changer for accessibility.”

But synchron’s advantages extend beyond safety. The Stentrode can record high-fidelity neural signals from the motor cortex, allowing patients to control a computer cursor, type, and even operate a wheelchair. The company is also developing a wireless version that communicates via Bluetooth.

“We are not trying to do everything at once,” said Oxley. “Our focus is on restoring function for people with severe physical limitations. That is a huge market.”

Neuralink, meanwhile, is aiming higher. Musk has spoken of achieving symbiosis with AI and treating a range of neurological conditions. The company has raised over $300 million and employs a star-studded team of scientists and engineers. But its timeline remains uncertain.

“Neuralink is playing a different game,” said Dr. Andrew Hires, a neuroscientist at the University of Southern California. “Their technology promises higher bandwidth and bidirectional communication. But they have to prove it works in humans without causing harm. That is a high bar.”

The FDA’s priority review for Synchron signals a shift in the regulatory landscape. The agency is under pressure to greenlight BCIs for patients with unmet needs. “The FDA is moving faster than ever for these devices,” said Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke. “They see the potential to transform lives.”

But questions remain. Synchron’s device currently has limited channels (16 electrodes), which restricts the complexity of commands. Competition from Neuralink could spur faster development. “We need more players in the field,” said Dr. Jennifer Collinger, a BCI researcher at the University of Pittsburgh. “But safety must come first.”

The race is far from over. Synchron has a head start, but Neuralink has deeper pockets and a more ambitious vision. Investors are watching closely. Synchron has raised $130 million from investors like Bill Gates and Jeff Bezos. Neuralink’s funding is private.

For patients like John, a 54-year-old with ALS who uses the Stentrode, the stakes are personal. “I can type again. I can communicate with my family. That is everything,” he said. “I don’t care who wins the race. I just want this technology to help more people.”

Synchron expects a final decision from the FDA within six to nine months. If approved, it will be the first commercially available BCI for paralysis in the US. Neuralink hopes to start human trials later this year. The future of mind-machine interfaces is being written now.