American startup receives FDA approval for less invasive brain implant than Elon Musk's Neuralink

The startup of the former co-founder of Neuralink has received approval from the US Food and Drug Administration (FDA) for a new type of brain implant that does not penetrate deep into the brain tissue, but is installed on its surface, Bloomberg reports.

Philadelphia-based Precision Neuroscience implanted its thin film into 63-year-old Parkinson’s patient Tim Fisher earlier this month. The surgeon placed a patch thinner than a human hair, embedded with 1,024 microelectrodes, directly on the surface of the patient’s cerebral cortex. After a brief training session, Fisher could control the robotic arm simply by thinking about moving his left hand, which sent impulses through the new implant.

"It was an amazing experience," said Fisher, a retail worker from West Chester, Pennsylvania. His tremors make it difficult for him to perform simple everyday tasks, such as typing or opening cans, so he hopes the technology will one day give him back fine motor control.

Last month, the FDA granted the implant an invasive clinical use authorization for up to 30 days to record, monitor, and stimulate brain activity. The approval is based on preclinical testing. Further clinical studies will help expand its use. A similar approval was previously granted to Blackrock Neurotech's NeuroPort Array device.

Precision Neuroscience was founded in 2021 by Michael Meagher and neurosurgeon Benjamin Rapoport, who previously helped create Elon Musk’s Neuralink. Unlike Neuralink’s chip-like implant with “threads,” the Precision pad can be inserted and removed without leaving any residual brain damage. The roughly one-square-inch (6.45 square centimeters) device has already been tested on at least 37 patients at five leading U.S. medical centers, and about a third of institutions that perform complex brain surgeries have expressed interest in the technology.

"We’ve been amazed by the demand for it," Rapoport said. The company plans to focus this year on collecting more patient data to refine the software that converts electrical signals into detailed, color maps of brain activity.

These high-precision maps give surgeons and researchers a “microscopic” level of detail about neural function, says neurosurgeon Nitin Tandon of UTHealth Houston. Tandon, who is not affiliated with Precision or other brain-computer interface companies, believes the technology could improve surgical planning — for example, avoiding areas responsible for movement during epilepsy surgery — and speed up research into speech and cognitive function.

Precision expects to begin commercial distribution of its implant in 2026. In the future, the company aims to use its development not only during surgical procedures, but also to create future wearable or implantable systems that will allow people with paralysis to communicate or control devices with the power of thought.

Fisher now fondly recalls his brief encounter with the robotic arm, joking that he had developed a "friendship" with the inactive object. "I even made a fist out of it," he said. "There was a sense of real connection with something that wasn't alive — but it felt very real."