Tag: Paradromics

7 articles

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

The BCI category is broadening beyond motor restoration in 2026

Across the first half of 2026 and the first weeks of the second half, three US Food and Drug Administration Breakthrough Device Designations were granted to non-motor-indication BCI and neuromodulation devices, Cortigent's existing Breakthrough-designated visual cortical prosthesis programme disclosed a secondary stroke motor rehab arm, three first-in-human or investigational-device clinical milestones landed, and two significant peer-reviewed publications extended the field's clinical use case. The motor-restoration pipeline itself continued to expand in the same window. This is a synthesis piece on what the data pattern actually shows and does not show.

Jul 13

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