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    Paradromics

    Also known as Paradromics Inc, Connexus BCI

    Paradromics develops the Connexus brain-computer interface, which uses 421 microelectrodes to record individual neurons and a chest-implanted transceiver to send data wirelessly through the skin.[1] FDA approved its Connect-One speech-restoration study in November 2025; the first participant was implanted in June 2026 and, according to the company, used the system for real-time speech by September 2026.[2][3][4]

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

    The device

    Connexus uses 421 microelectrodes, each thinner than a hair, that reach 1.5 millimetres below the brain’s surface to record individual neurons as they fire.[1] The array sends data to a transceiver implanted in the chest, which transmits wirelessly through the skin to an external receiver.[1] In preclinical testing the company says it exceeded 200 bits per second of information transfer, a figure measured in animals, not people.[5] Paradromics says Connexus is meant for people whose speech or use of technology is limited by severe motor impairment from conditions such as ALS, spinal cord injury or stroke.[6] It also lists a second device, Tempo, designed for people who are up and about and for mobile BCI uses; Tempo is still in the preclinical phase.[7]

    Connect-One trial

    In November 2025 FDA granted Paradromics an Investigational Device Exemption for Connect-One, an early feasibility study to test whether Connexus can safely restore speech and computer control in people with severe motor impairment. The study initially enrols two participants.[2] Sites include UC Davis, Massachusetts General Hospital and the University of Michigan.[8] Paradromics says it was the first company to receive IDE approval for speech restoration with a fully implantable BCI.[9]

    On June 17, 2026 the company and University of Michigan Health announced the first implant, in a woman with motor neuron disease who has difficulty speaking.[3] In July 2026 the company appointed William J. Marks Jr., a neurologist and former Verily leader, as chief clinical officer to guide clinical strategy and regulatory planning.[10] In August 2026 Paradromics said FDA had approved expanding the study so participants can use the BCI with personal computing devices.[11]

    First results

    In September 2026 Paradromics said the first participant had used Connexus for real-time speech and text. The company said she chose her own words, answered open-ended questions and spoke with her grandchildren on a live phone call. Local news coverage by CBS Austin reported the same milestone, based on the company’s announcement.[4] It did not publish accuracy, speed or vocabulary figures, so the result cannot yet be compared with peer-reviewed speech neuroprostheses such as the UC Davis system that held 97.5 percent accuracy over 8.4 months.[4][12]

    How it compares

    Connexus is one of several approaches now in human trials. Neuralink uses flexible threads inserted by a robot, Synchron goes through blood vessels and Precision Neuroscience uses a surface film.[13][14][15] Paradromics and Neuralink are both running speech studies; Neuralink’s VOICE trial aims for 140 words per minute.[2][16] Speech-BCI intellectual property from the University of California has been licensed to Paradromics, according to a 2025 paper’s disclosures.[17]

    Regulatory path

    Connect-One is an early feasibility study, the first stage of FDA’s pathway for implanted BCIs; larger pivotal studies would come later.[18][2] As of December 2024, FDA had not granted marketing authorization to any implantable BCI.[19]

    Durability

    Penetrating electrodes can lose signal if they shift, as Neuralink found with thread retraction in its first participant.[20] In October 2026 Paradromics reported four years of stable spike recordings in two sheep implanted with modules representative of its electrode technology, with no array migration observed.[21] Human data over comparable periods do not yet exist for Connexus, whose first human implant was announced in June 2026.[3]

    Questions readers ask

    What is the Connect-One study?

    An FDA-approved early feasibility study of the Connexus BCI for restoring speech and computer control in people with severe motor impairment. It initially enrols two participants.[2]

    Has Connexus restored speech?

    Paradromics said in September 2026 that its first participant, a woman with motor neuron disease, used Connexus for real-time speech and text communication. It did not publish accuracy or speed figures, and the result has not been peer-reviewed.[4][3]

    How long do the electrodes last?

    Paradromics reported four years of stable recording in two sheep in October 2026. Long-term durability in people has not yet been shown.[21]

    Sources

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

    1. [1]

      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

    2. [2]

      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

    3. [3]

      On June 17, 2026 Paradromics and University of Michigan Health announced the first Connexus implantation in the Connect-One study, in a woman with motor neuron disease who has difficulty speaking. confirmedas of 2026-06-17

    4. [4]

      In September 2026 Paradromics said its first Connect-One participant had used Connexus for real-time speech and text communication, choosing her own words and answering open-ended questions; the company did not publish accuracy or speed figures. confirmedas of 2026-09-14

    5. [5]

      Paradromics says Connexus exceeded 200 bits per second of information transfer in preclinical testing. confirmedas of 2026-10-10

    6. [6]

      Paradromics says Connexus is designed for people whose speech or control of technology is limited by severe motor impairment from conditions such as ALS, spinal cord injury or stroke. confirmedas of 2026-10-10

    7. [7]

      Paradromics lists a second device, the Tempo BCI, designed for ambulatory users and mobile BCI applications, as being in the preclinical phase. confirmedas of 2026-10-10

    8. [8]

      Connect-One sites include UC Davis, Massachusetts General Hospital and the University of Michigan. confirmedas of 2025-11-20

    9. [9]

      Paradromics says it was the first company to receive IDE approval for speech restoration with a fully implantable BCI. confirmedas of 2025-11-20

    10. [10]

      In July 2026 Paradromics appointed William J. Marks Jr., a neurologist and former Verily leader, as chief clinical officer to guide clinical strategy and regulatory planning as Connect-One proceeds. confirmedas of 2026-07-07

    11. [11]

      In August 2026 Paradromics said FDA had approved expanding the Connect-One study to give participants BCI access to personal computing devices. confirmedas of 2026-08-26

    12. [12]

      The UC Davis neuroprosthesis reached 99.6 percent accuracy on a 50-word vocabulary on its first day of use and sustained 97.5 percent accuracy over 8.4 months, with the participant conversing at about 32 words per minute for more than 248 hours. confirmedas of 2024-08-15

    13. [14]

      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

    14. [15]

      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

    15. [17]

      According to the competing-interest disclosures of a 2025 Nature paper, Stanford University speech-decoding intellectual property has been licensed to Blackrock Neurotech and Neuralink, and University of California speech-BCI intellectual property has been licensed to Paradromics. confirmedas of 2025-06-12

    16. [18]

      FDA issued final guidance in May 2021 on non-clinical testing and clinical study design for implanted BCI devices for patients with paralysis or amputation, covering both feasibility and pivotal studies. confirmedas of 2021-05-20

    17. [19]

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

    18. [21]

      In October 2026 Paradromics reported four years of stable neural recording in two sheep implanted with cortical modules representative of its electrode technology, with no electrode-array migration observed. confirmedas of 2026-10-08

    19. [22]

      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. [23]

      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

    Revision history (2)
    1. Page created.
    2. Refresh: added target conditions, the Tempo device, the chief clinical officer appointment, a second source for the speech result and a regulatory-path section.

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

    Cite this page

    "Paradromics." ContentLora, updated Oct 10, 2026. https://contentlora.com/wiki/paradromics

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