Tag: Connect-One

5 articles

Industry News

Paradromics's first Connexus participant used a brain implant to speak her own words

Paradromics announced on 14 September 2026 that the first participant in its Connect-One Early Feasibility Study, a Michigan woman in her 60s with progressive motor neuron disease and severe dysarthria, has used the Connexus intracortical brain-computer interface to generate her own words, answer open-ended questions, and hold a live phone call with her grandchildren, three months after her June 2026 implant at University of Michigan Health. Verbatim first sentence: 'Okay, I have a lot to say.' Second sentence: 'Don't be afraid. It's a wonderful experience to be able to help others by your participation in the research study.' Both were decoded in real time, word for word, with no errors, according to Paradromics. Output modality is text plus synthesized speech (not avatar-mediated). Quantitative benchmarks (words per minute, word-error rate, vocabulary size, decoding latency) were not disclosed. The Connect-One EFS runs across three sites (University of Michigan Health, UC Davis Health, Mass General Brigham) under FDA IDE approval granted in November 2025. Same-day academic milestone at UCSF (Edward Chang team, Nature Neuroscience) demonstrates simultaneous speech and gesture decoding via animated avatar. The two results are categorically different (commercial vs academic, text-plus-audio vs avatar-mediated) and should not be conflated.

Sep 16

Industry News

Paradromics wins FDA approval to connect its Connexus BCI to personal laptops, tablets and phones inside Connect-One

Paradromics announced on 26 August 2026 that the US Food and Drug Administration has issued an approval letter expanding the types of computing devices that may be used with its Connexus brain-computer interface inside the Connect-One Early Feasibility Study. Compatible personal, internet-connected devices (laptops, tablets, phones) can now be added into the study without a per-device FDA approval. Paradromics also identified a second patient for the feasibility study, and its first patient has progressed to closed-loop stage.

Aug 26

Market Moves

Paradromics hires Verily's former head of clinical neurology as Chief Clinical Officer

Paradromics announced on 7 July 2026 that William J. Marks, Jr., MD, MS-HCM, has joined as Chief Clinical Officer, a role distinct from the Chief Medical Officer position held by neurosurgeon Stephen Ryu. Marks was Head of Clinical Neurology and Head of Clinical Science at Verily Life Sciences from 2016 to 2023, before co-founding Nexus NeuroTech Ventures, which wound down 31 March 2026. The hire lands three weeks after Paradromics' first-in-human Connexus BCI implant at University of Michigan Health on 17 June 2026.

Jul 7