Subcategory of brain-computer-interface. Devices that connect to the brain
itself — cortex or deeper — rather than the eye. Covers motor/speech BCIs and
cortical visual prostheses.
Stimulate visual cortex to create phosphenes — see below
Cortical visual prostheses (bridge subcategory)
Neuralink Blindsight — FDA Breakthrough Device designation (2024); implant in
visual cortex fed by a camera; intended for patients blind from any cause with an
intact visual cortex; Musk: initially “like Atari graphics”; first human implants
expected ~2026 (statements 2026); see cortical-visual-prosthesis.
Cortigent Orion — continuation of the retinal-prosthesis-adjacent Second
Sight program; 60 electrodes on the visual cortex; 6-yr Early Feasibility Study
results (NANS Jan 2026); company (Vivani Medical subsidiary, S-1 filed for Nasdaq
ticker CRGT) is pivoting away from the Argus II; see cortigent.
Phosphoenix (NL) — Roelfsema’s spin-off; 1,024-channel macaque proof
(Science 2020); now targets the LGN with the Fountain Probe; see phosphoenix.
ReVision Implant (BE) — “Occular” deep intracortical V1 arrays, >1,000
electrodes; FDA Breakthrough; FIH scheduled Q3 2026; see revision-implant.
Monash Vision Group Gennaris (Australia) — ~172-electrode cortical implant;
first-in-human trials being planned; preclinical validation in large animals.
N1 first human Jan 2024; Blindsight FDA Breakthrough
$650M Series E (June 2025)
Synchron
US
Stentrode (endovascular)
FDA IDE 2021; ~10 patients
Bezos/Gates backed
Blackrock Neurotech
US
Utah arrays (NeuroPort, BIP)
Long-standing human trials
—
Precision Neuroscience
US
Layer 7
FDA 510(k) clearance 2025 (30-day use)
—
Paradromics
US
Connexus (1,600 ch)
FDA IDE Nov 2025; first human surgery June 2025
$108.6M total
Stairway Medical
China
—
—
$48M Series B (Feb 2025), largest China BCI round
Cortigent
US
Orion (cortical vision)
FDA Breakthrough; S-1 filed
Vivani Medical subsidiary
Case study: Paradromics Connexus first-in-human (June 2025)
First human implant/recording at University of Michigan Health during an epilepsy
resection (temporal lobectomy); led by Matthew Willsey, MD, PhD with senior
epilepsy surgeon Oren Sagher, MD; team incl. Joseph Costello, Matthew Mender,
Enrico Opri, William Stacey.1
Connexus (wireless, fully implantable) recorded brain signals and was removed intact
in <20 minutes using standard surgical techniques; followed ~3 years of preclinical
studies with the same device; “first of many surgeries” planned. Target indication:
ALS, brainstem stroke, spinal cord injury.1
Device specs reported: penny-sized, 421 microelectrodes (U-M BME article) vs 1,600-channel
platform figure — discrepancy flagged for verification (see paradromics).2
Long-term use/safety trial planned for later 2025 → Connect-One study (FDA IDE Nov 2025).1
Open questions
Channel count vs. long-term safety: 100s (clinical standard) vs. 1,000s+
(needed for rich perception/vocoding) — see comparisons like Paradromics/Neuralink.
Whether cortical vision (any-blindness generality, e.g. Blindsight) beats retinal
(form-vision readability but disease-limited, e.g. PRIMA) in the long run:
see retinal-prosthesis-companies and brain-computer-interface.