Neural Noise

Paradromics

3 min read

  • Paradromics, a BCI company, appointed a new chief medical officer (April 2025).1
  • The CMO appointment signals preparation for clinical and regulatory steps.1 1

Gardner updates

  • Paradromics (Austin-based neurotechnology company) successfully implanted its device on a patient’s brain, marking a major invasive BCI player in first-in-human phase (June 2025). 2

  • Paradromics (Austin-based) reported a successful human brain implant in a patient, marking another major invasive BCI company in first-in-human phase. 2

  • Paradromics completed its first human BCI test and is preparing for clinical trial (Spectrum News); first-in-human milestone for the company and clear move toward formal trial. 3

  • Paradromics received FDA approval for the Connect-One clinical study with the Connexus BCI for speech restoration (FDA IDE milestone; first-in-human high-channel-count invasive speech BCI trial). 4

  • Paradromics CEO Matt Angle argued that human thought is approximately 10–50 bps and explained why BCIs still need high-resolution I/O for rich control, agency, and user experience. 5

  • Paradromics CEO Matt Angle argues that a genuine commitment to BCI users requires rigorous accountability and that measuring what matters in BCI should drive how the field defines and reports outcomes. 6

Weekly enrichment (2026-07-20)

  • Each Connexus cortical module packs 421 platinum-iridium microwire electrodes (~1.55 mm long, <40 µm diameter) reaching ~1.5 mm beneath the cortical surface; up to four modules combine for 1,684 intracortical channels recording single-neuron activity.78
  • In preclinical models the Connexus BCI achieved a record information-transfer rate exceeding 200 bits per second (~20× faster than existing BCIs) with roughly 56 ms system latency.78
  • The system is fully internalized and wireless: a subclavicular internal transceiver relays data over a secure near-infrared optical link at ~100 Mbit/s to a wearable external transceiver, which also powers the implant via inductive coupling (the same principle as wireless phone charging).78
  • Connexus components are modeled on cardiac pacemakers and DBS stimulators and are hermetically sealed for chronic implantation, eliminating the percutaneous infection risk of skin-penetrating connectors.7
  • First-in-human acute recording occurred on 14 May 2025 (announced 2 June 2025) at University of Michigan Health: a team led by neurosurgeon Matthew Willsey implanted Connexus during an epilepsy resection, recorded signals, and removed it intact in under 20 minutes, following roughly three years of preclinical (sheep) studies.910
  • The FDA granted an Investigational Device Exemption for the Connect-One Early Feasibility Study in November 2025, making Paradromics the first company with IDE approval for speech restoration using a fully implantable BCI.1112
  • Connect-One (ClinicalTrials.gov NCT07357428) is a single-group early-feasibility study that started 31 March 2026, is recruiting an estimated 2 participants, with primary completion estimated May 2027 and full study completion estimated January 2032.13
  • Eligible participants have impaired speech and limited upper- and lower-extremity movement from severe loss of voluntary motor control, must live within four hours of one of three US sites (Michigan, California, Massachusetts), and will be followed for six years post-implant.1113
  • Company/funding context: Paradromics (founded 2015, Austin, Texas) raised a $33M Series A led by Prime Movers Lab (with Westcott Investment Group, Dolby Family Ventures, and Green Sands Equity) and holds FDA Breakthrough Device Designation; the first chronic Connect-One implant was placed in a woman from Michigan by Drs. Willsey and Aditya Pandey.1112

Footnotes

  1. https://news.google.com/rss/articles/CBMieEFVX3lxTE1UUmgwYVZGeUlfUVM4VDlvaGVReXVQRWR3cXRoWmNkdXBOaEhZSUVSNjcwZFk3VUFVYnpnaU5kMjgyd3dMeEFDOV9CdDBhSENFeC1UcTFpQ2NlVTJjaHJCOEdqeE5yOU85cFRyODJrUUhKdmUyVEFuZQ?oc=5 ↩ ↩2 ↩3

  2. https://news.google.com/rss/articles/CBMi4gFBVV95cUxOOFZZeUN0RG5TRTNkWnlqZlFheDZPSmI1aDBpUmtKZWpIV2UxMkNMNXdoWUt3Q3BCZzhURXk3U3d0aWk5TEZSMnJ3bm1lYnk3NjUzOHlJd3pqeTFmSzJBenBvWG85aDBPTEFJajhQMDhnZFl2cGlDSTdIcWdGSW10OFFWV3l2M1M2M2Fwd1ZYbktSM01vbnFTSHZ5SUNBeU9mNzBubDJCS0pndFRjRU95bW1oNFRVb1lDWUZpcm5JY09udnZHUlhEejlGYXNOQWY1SHdaX2lQUVJxelpnelg3MGNn?oc=5 ↩ ↩2

  3. https://news.google.com/rss/articles/CBMilgFBVV95cUxNUENzYXp4QU10QTh5VDZtWHVONzNURlJPS0F0MFJiUHJEQ3pwU2dvaWE3RXBkR0E0UEpGQzcxUS1ta0tPdlVGTjJHb0lNdk82QXozZkhKVVZ6YlllY2dQeDE2cHhadzRzQmRlVU5USFcwQlJfVGhubEtDUWxpMlR2SzhKeGxlbW5RQVE3QWlUZzJXRUxGRnc?oc=5 ↩

  4. https://news.google.com/rss/articles/CBMimgFBVV95cUxNNjQ0amhMWXV1ajNHQ0RITnlFYTRaRG5mdFNWcEZQSmFfeXBhLW93LXRUUDFWRmNIMEFsUnFvZlNKT1plRUx3aUpYeS1sbjFzcEJsZVNMTkdjZDM0elhmaVlILUY4TzZXcGFTN1E2Qm15OTdHdHotZktDOEp0VGpINHdhWkhlZzZLdmNEbi1ZSWpvdVFpWTdqc3JR?oc=5 ↩

  5. https://paradromics.substack.com/p/the-speed-of-human-thought-and-its ↩

  6. https://paradromics.substack.com/p/measuring-what-matters-in-bci ↩

  7. https://paradromics.com/connexus/ ↩ ↩2 ↩3 ↩4

  8. https://bciintel.com/devices/paradromics-connexus/ ↩ ↩2 ↩3

  9. https://www.paradromics.com/news/paradromics-completes-first-in-human-recording-with-the-connexus-brain-computer-interface ↩

  10. https://www.upi.com/Health_News/2025/06/02/paradromics-brain-computer-interface-implanted-human/4661748897835/ ↩

  11. https://www.michiganmedicine.org/news-release/university-michigan-implants-first-human-paradromics-wireless-brain-computer-interface-designed ↩ ↩2 ↩3

  12. https://paradromics.com/news/paradromics-raises-33-million-in-funding-achieves-breakthrough-medical-device-designation-from-fda/ ↩ ↩2

  13. https://clinicaltrials.gov/study/NCT07357428 ↩ ↩2

Graph View