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    Precision Neuroscience

    Also known as Precision, Layer 7 Cortical Interface

    Precision Neuroscience develops Layer 7, a thin film of 1,024 electrodes that rests on the surface of the brain rather than penetrating it.[1] In April 2025 it became the first next-generation BCI company to receive full FDA clearance, a 510(k) for implantation of up to 30 days, and by October 2026 it reported more than 100 implanted study patients.[2][3][4]

    Editor reviewedStrict sourcingUpdated Neuroscience and brain-computer interfacesHealth and medicineLife sciences
    Key facts

    What it builds

    Layer 7 is a flexible thin-film array with 1,024 electrodes on a device about the size of a postage stamp.[1] It rests on the cortex instead of penetrating it, which places it among the surface-array approaches to recording brain activity.[1]

    The company says the device is designed to be removable and upgradable without damaging the brain.[5]

    A 2025 paper by Precision researchers, published in Nature Biomedical Engineering, described the array in detail. The team delivered the 1,024-channel film without a craniotomy, the usual removal of a piece of skull, in pigs and human cadavers, and used the same electrodes both to record and to stimulate the cortex. It also reported using the device during surgery in a five-patient pilot study. Most authors are current or former employees or advisers of the company and own stock in it.[6]

    Regulatory status

    In April 2025 FDA granted Layer 7 510(k) clearance, authorizing commercial use with implantation of up to 30 days.[2] The clearance covers recording, monitoring and stimulating electrical activity on the brain’s surface, and lets Precision market the array for clinical uses such as mapping the brain during surgery.[7] Precision described it as the first full regulatory clearance for a company developing a next-generation wireless BCI.[3] The clearance covers short-term use; it is not an authorization for a permanent, at-home BCI.[2]

    That distinction matters. As of December 2024, FDA had not authorized any implantable device for long-term BCI use.[8]

    Clinical experience

    At the time of its clearance, Precision said it had tested Layer 7 in 37 patients.[9] By October 2026 it reported more than 100 implanted clinical study patients and more than 18 active hospital partners.[4] The company’s published research titles describe high-resolution cortical mapping with the 1,024-electrode array.[1] Short-term use during surgery gives the company human recordings before any long-term implant is approved, which is the route its 2025 pilot study followed.[6][7]

    Surface arrays versus penetrating electrodes

    Surface arrays record from many sites at once without entering brain tissue.[1] Penetrating arrays, by contrast, record spiking from small groups of neurons and supported the 62-words-per-minute Stanford speech result.[10][11] Implanted electrodes in general give stronger, more precise signals than wearable systems, but every implant requires surgery.[12][13]

    Funding

    Precision closed a $250 million Series D in 2026, led by Pershing Square, the Ackman Oxman Institute and a life-sciences fund. The round brought total funding to $430 million and is meant to expand clinical programs, take Layer 7 through further FDA review and build commercial infrastructure.[14]

    Where it fits

    Precision competes with Neuralink and Paradromics, whose electrodes penetrate brain tissue, and with Synchron, which goes through blood vessels.[15][16][17] Surface arrays have a track record in speech research: a 2023 UCSF study used high-density surface recordings to decode attempted speech at a median 78 words per minute.[18] In 2025 the same group used surface recordings to drive a streaming speech synthesizer in the participant’s pre-injury voice, decoding in 80-millisecond steps.[19] Those were academic studies, not tests of Layer 7, so they show what surface recording can do in principle rather than what Precision’s device has done.[18][4]

    Questions readers ask

    Is Precision's implant FDA approved?

    Layer 7 has FDA 510(k) clearance for use with implantation of up to 30 days. It is not authorized as a permanent implant.[2]

    Does Layer 7 go into the brain?

    No. It is a thin film that sits on the brain's surface, and the company says it is designed to be removable without damaging the brain.[1][5]

    How many people have used it?

    Precision said it had tested the device in 37 patients by April 2025, and reported more than 100 implanted clinical study patients by October 2026.[9][4]

    Sources

    Each numbered claim is a statement we checked against the sources listed with it. Status shows how well established it is.

    1. [1]

      Layer 7 is a thin-film surface electrode array with 1,024 electrodes on a device about the size of a postage stamp. confirmedas of 2026-10-10

    2. [2]

      In April 2025 Precision Neuroscience received FDA 510(k) clearance for its Layer 7 Cortical Interface, authorizing commercial use with implantation of up to 30 days. confirmedas of 2025-04-17

    3. [3]

      Precision described the 510(k) as the first full regulatory clearance granted to a company developing a next-generation wireless BCI. confirmedas of 2025-04-17

    4. [4]

      As of October 2026 Precision Neuroscience reports more than 100 implanted clinical study patients and more than 18 active hospital partners, and says its device is designed to be removable without damaging the brain. confirmedas of 2026-10-10

    5. [5]

      Precision says Layer 7 is designed to be removable and upgradable without damaging the brain. confirmedas of 2026-10-10

    6. [6]

      A 2025 paper by Precision Neuroscience researchers described delivering its 1,024-channel thin-film array without a craniotomy in pigs and cadavers, and reported intraoperative use in a five-patient pilot study. confirmedas of 2025-10-02

    7. [7]

      Precision's 2025 clearance covers Layer 7 for recording, monitoring and stimulating electrical activity on the brain's surface, and lets the company market it for clinical uses such as mapping the brain during surgery. confirmedas of 2025-04-17

    8. [8]

      As of December 2024, FDA had not granted marketing authorization for any implantable device for BCI use. confirmedas of 2024-12-17

    9. [9]

      At the time of its April 2025 clearance Precision said it had tested its device in 37 patients. confirmedas of 2025-04-17

    10. [10]

      A 1997 study described the Utah Intracortical Electrode Array as a recording structure for brain-computer interfaces, recording from small populations of neurons with an average signal-to-noise ratio of 6 to 1. confirmedas of 1997-03-01

    11. [11]

      A 2023 Stanford study decoded the attempted speech of a participant with ALS from intracortical arrays at 62 words per minute, with word error rates of 9.1 percent on a 50-word vocabulary and 23.8 percent on a 125,000-word vocabulary, and found a detailed articulatory representation of phonemes persisting years after paralysis. confirmedas of 2023-08-23

    12. [12]

      Implantable BCIs let users control devices faster and more precisely than wearable BCIs because they measure signals directly from the brain, making the signals stronger and more precise. confirmedas of 2024-12-17

    13. [13]

      The risks of brain surgery currently limit participation in implantable BCI clinical trials to people with severe disabilities. confirmedas of 2024-12-17

    14. [14]

      Precision Neuroscience closed a $250 million Series D in 2026, bringing its total funding to $430 million, to expand clinical programs, pursue further FDA review of Layer 7 and build commercial infrastructure. confirmedas of 2026-10-10

    15. [16]

      The Connexus BCI uses 421 microelectrodes that reach 1.5 millimetres below the brain's surface to record individual neurons, with a transceiver in the chest that transmits data wirelessly through the skin. confirmedas of 2026-10-10

    16. [17]

      The SWITCH study delivered Stentrode recording electrodes by catheter through the jugular vein to the superior sagittal sinus, avoiding open-brain surgery. confirmedas of 2023-03-01

    17. [18]

      A 2023 UCSF study used high-density recordings from the surface of the speech cortex to decode text at a median 78 words per minute with a median word error rate of 25 percent, and to drive a speaking facial avatar. confirmedas of 2023-08-23

    18. [19]

      A 2025 UCSF study used high-density surface recordings to drive a streaming speech synthesizer in the participant's pre-injury voice, decoding in 80-millisecond increments. confirmedas of 2025-03-31

    19. [21]

      As of November 2025 Synchron's Stentrode had been implanted in 10 patients with paralysis across trials in the US and Australia. confirmedas of 2025-11-06

    20. [22]

      In November 2025 FDA granted Paradromics an Investigational Device Exemption for the Connect-One early feasibility study of its Connexus BCI to restore speech and computer control, initially enrolling two participants. confirmedas of 2025-11-20

    Revision history (2)
    1. Page created.
    2. Refresh: added the 2025 Nature Biomedical Engineering paper on minimally invasive delivery and the scope of the 510(k) clearance.

    Created Oct 10, 2026. Last reviewed by an editor on Oct 10, 2026. Next scheduled review: Jan 10, 2027.

    Cite this page

    "Precision Neuroscience." ContentLora, updated Oct 10, 2026. https://contentlora.com/wiki/precision-neuroscience

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