Neural Noise

BCI Annual Review :: 2025

7 min read

2025 at a glance

Clinical and commercial

  • Second commercial cortical path: FDA clearance for Precision Neuroscience’s minimally invasive implant (April).
  • First U.S. clinical test of BCI for speech/language decoding at WVU Rockefeller Neuroscience Institute (April).
  • Paradromics first‑in‑human Connexus (June).
  • Neuralink: $650M Series E, expansion to the Miami Project, 12 human implants by September, planned speech‑impairment trial, first peer‑reviewed human data, and ~10,000‑person waitlist by year‑end.
  • University of Michigan Health opened one of the first dedicated BCI clinics in the U.S.

Applications and hardware

  • Speech and communication BCIs: streaming brain‑to‑voice, handwriting decoding, inner speech, Mandarin decoding, and non‑invasive word‑level decoding moving from demos toward product paths.
  • Sensory and closed‑loop: stumble‑recovery neuroprosthesis, bionic hands with tactile feedback, LUKE Arm real‑world use, movement‑responsive DBS, chronic‑pain implants, finger‑level robotic hand control.
  • Hardware scale: 65,536‑electrode wireless subdural BCI and ultra‑thin BISC‑style implants targeting epilepsy, paralysis, and blindness.

Governance and policy

  • Regulatory: multiple FDA clearances (Precision, ONWARD ARC‑EX home use, tDCS for depression), IDE approvals (Paradromics, ONWARD), CE marks, and growing reimbursement focus.
  • Governance: Frontiers ethics/regulation paper, Barcelona AIMD workshop, ICRC on BCIs and humanitarian law, U.S. neural‑data bill, the proposed MIND Act, WEF “neurosecurity stack,” UNESCO’s global neurotech ethics standard, and Nature on preconscious‑state inference.

Timeline

January

  • Closed‑loop stumble recovery – Nature paper on a sensory neuroprosthesis improving stumble recovery in lower‑limb loss.
  • Prosthetic touch in daily life – Bionic hands giving shape and movement feedback on prosthetic “skin.”
  • LUKE Arm in the wild – First day‑to‑day trial at University of Utah.
  • High‑resolution motor BCIs – Blackrock Neurotech arrays enabling finger‑level control from decoded motor intent.
  • Implant durability and clinical neurophysiology – Work on silicon IC degradation, PDMS barriers, hippocampal memory neurofeedback, multibranch CNNs plus high‑frequency oscillations for seizure prediction, and an international TMS–EEG update in Clinical Neurophysiology.

February

  • Invasive BCI in chronic stroke – Intracortical designs for long‑term motor restoration.
  • Decoders and dynamics – Multiscale spiking decoders, tensor methods for neural dynamics.
  • Stimulation‑aware modeling – Stim‑BERT for reconstructing iEEG during stimulation.
  • Next‑gen interfaces – Nature review on soft, biohybrid, and “living” neural interfaces.

March

  • Streaming brain‑to‑voice – Nature paper on a continuous speech neuroprosthesis.
  • Handwriting as neural states – Motor cortex encoding of handwriting as stable neural states.
  • “Finding a New Voice” – Rush University speech BCI work.
  • Imagined‑action control – Paralyzed participant controlling a robotic arm with imagined actions.
  • Spinal cord stimulation plus robotics – Combined with rehab robotics for cycling and walking.
  • Real‑world invasive recording – Downhill skiing recordings in Parkinson’s disease.
  • Policy enters the frame – New America analysis on neurotech growth and brain‑data privacy/security.

April

  • Second commercial cortical path – FDA clearance for Precision Neuroscience’s minimally invasive brain implant.
  • First U.S. BCI speech test – WVU Rockefeller Neuroscience Institute decodes speech and language.
  • Multimodal semantics – EEG+fNIRS for semantic decoding.
  • Conversation analytics – NLP‑based analyses of conversational dynamics.
  • Transparent interfaces – PEDOT:PSS devices for simultaneous electrophysiology and imaging.
  • Ultrasoft probes translated – Fleuron probes move toward clinical use.
  • Home neuromodulation – Sham‑controlled home tACS trial for Alzheimer’s.
  • VA neurofeedback – Individualized neurofeedback for concussion backed by the VA.

May

  • BCI meets Apple platforms – Synchron announces native integration with iPhone, iPad, and Vision Pro.
  • New wireless BCI in humans – University of Michigan reports first in‑human recordings.
  • Non‑invasive startup Nudge – Launched by Coinbase co‑founder Fred Ehrsam.
  • Axon‑R access – Cognixion + Blackrock expand multimodal non‑invasive research access.
  • Stability and crosstalk – Latent‑dynamics alignment for long‑term stability and crosstalk quantification in brain recordings.
  • Open datasets and ontologies – New iEEG datasets for epilepsy and conscious perception; Neuroelectrophysiology Analysis Ontology (NEAO).

June

  • Paradromics first‑in‑human – Connexus procedure completed.
  • Neuralink Series E and Miami implant – Funding round plus a paralyzed veteran implant at the Miami Project.
  • Blackrock vs Neuralink narrative – Blackrock framed publicly as a more advanced alternative.
  • Language encoding – ECoG work on syntactic roles and timing in sentence production.
  • Movement‑responsive DBS – Nature paper on DBS with remotely optimized decoder.
  • Chronic‑pain implant – USC/UCLA wireless AI‑driven implant for chronic pain.
  • Finger‑level robotic control – EEG‑based real‑time control of a robotic hand at individual finger level (Nature).
  • Neurofeedback at scale – Myndlift passes one million sessions; UConn launches a neuromodulation center of excellence for veterans.

July

  • Cross‑subject neural code conversion – Inter‑individual and inter‑site conversion without shared stimuli.
  • Emotion and decoding – Contrastive learning for cross‑subject EEG emotion recognition; hybrid deep‑learning EEG‑BCI classifiers.
  • Holographic ultrasound – Holographic transcranial ultrasound for neuromodulation.
  • tACS/tDCS protocols – Phase‑synchronous tACS for memory, HD‑tDCS for insomnia, anodal tDCS for rationality.
  • Minimally invasive pain electrodes – Extra‑epidural electrodes for pain management.
  • ARC‑EX to regulators – ONWARD submits ARC‑EX to FDA for home use and CE mark.
  • Ethics and AIMDs – Frontiers paper on ethics/regulation for implantable BCIs and the Barcelona AIMD workshop.

August

  • Inner‑speech BCI hits press – Stanford/BrainGate real‑time inner‑speech decoding from intracranial signals, with wide coverage and mental‑privacy debate.
  • Everyday Stentrode control – Stentrode‑based control of consumer devices.
  • Paradromics toward trial – First‑in‑human milestone and trial preparation.
  • Neuralink’s first‑participant narrative – Public account of first participant experience.
  • Ultra‑dense SiNAPS – Corticale’s SiNAPS design showcasing high‑density invasive hardware.
  • ARC‑IM IDE – ONWARD receives FDA IDE for ARC‑IM Empower BP pivotal study.
  • Closed‑loop ethics – Scoping review on ethical gaps in closed‑loop neurotechnology and ICRC piece on BCIs and humanitarian law.

September

  • Neuralink at scale – 12 human implants reported; planned speech‑impairment trial.
  • Precision’s first‑in‑human data – Early results for its minimally invasive cortical interface.
  • Science Corp registry – Patient registry opened for sight‑restoring BCI.
  • Speech decoding advances – Deep‑learning linguistic decoding, transfer learning across distributed recordings, mimed‑speech as a bridge between overt and imagined speech in ECoG.
  • ARC‑EX in Europe – ONWARD receives CE Mark; ARC‑IM data on blood‑pressure control after spinal cord injury.
  • Neural‑data legislation – U.S. neural data bill introduced in Congress.
  • Clinician views on closed‑loop AI – Nature reports perspectives on explainability in AI‑driven closed‑loop neurotechnology.

October

  • Neuralink evidence phase – First peer‑reviewed human clinical data submitted; ~10,000‑person waitlist reported.
  • Time’s Best Inventions – Synchron’s Stentrode and Ceribell’s point‑of‑care EEG named to the list.
  • MIND Act introduced – U.S. senators propose the MIND Act to explore national neural‑data standards.
  • Neurosecurity stack – World Economic Forum advances a technology‑neutral neuro‑privacy and “neurosecurity stack” framing.
  • No model law yet – Commentators flag the lack of international model law for neurotechnology.
  • Technical advances – iEEG speech timing work, EEG imagined‑speech database, silk‑based conformal intraventricular interfaces, invasive mapping for personalized OCD neuromodulation targets, and a hair‑thin electrode design that roughly triples recording duration.
  • Industry consolidation – MindMaze merger; ONWARD revenue and fundraising milestones.

November

  • Mandarin decoding in real time – Science publishes full‑spectrum real‑time Mandarin decoding from neural signals.
  • Non‑invasive word decoding – Nature shows progress toward decoding individual words from non‑invasive recordings.
  • Connect‑One trial approval – FDA approves Paradromics’ speech BCI trial.
  • UNESCO ethics standard – First global standard on neurotechnology ethics adopted.
  • MIND Act debate – Frames the U.S. neural‑data conversation.
  • Preconscious inference concerns – Nature asks whether devices inferring preconscious states need new safeguards.
  • Invasive funding milestone – Synchron raises a $200M Series D; analyst reports suggest invasive BCI funding passes $1B.
  • ONWARD and Ceribell clearances – ONWARD gets expanded FDA clearance for ARC‑EX home use; Ceribell wins clearance for neonatal seizure detection.

December

  • 65,536‑electrode wireless BCI – Nature reports a wireless subdural system with 65,536 electrodes and 1,024 channels.
  • Ultra‑thin BISC‑like implant – Tens of thousands of electrodes with AI decoding of movement, perception, and intent aimed at epilepsy, paralysis, blindness.
  • Race to the clinic – Nature frames the year as “Brain–computer interfaces race to the clinic.”
  • First tDCS depression approval – First U.S. approval of a tDCS‑based depression treatment.
  • Dedicated BCI clinic – University of Michigan Health opens a BCI clinic.
  • Functional outcomes – Neuralink recipient with ALS reported gaining communication/control capabilities.
  • Regulatory expectations – AdvaMed IDE workshop focuses on neurotech regulatory expectations.

Graph View