Tag: FDA-Breakthrough-Device

2 articles

Industry News

Neuralink discloses direct thought-to-audio speech decoding in ALS participant Terry, the VOICE trial's third implantee

Neuralink published a video this week showing Terry, a married man with bulbar-onset ALS, saying 'Hello, how are you doing today?' and 'I, I love you' to his wife through an implanted N1 brain-computer interface. The output routed through Grok Voice, xAI's speech engine, using a clone of Terry's own pre-ALS recordings. It is Neuralink's most detailed publicly disclosed thought-to-speech demonstration to date and the first to route through xAI's Grok Voice engine for personalised voice synthesis. Another VOICE participant, Kenneth Shock, appeared in a Neuralink clip on 16 September 2026, two days before Terry's disclosure, saying 'I love you' to his wife. Terry is the third participant in Neuralink's VOICE early-feasibility trial (ClinicalTrials.gov NCT07224256), formally titled 'VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration.' VOICE is a separate protocol from Neuralink's PRIME motor-decoding trial and its CAN-PRIME and GB-PRIME international arms. The N1 implant holds an FDA Breakthrough Device Designation; it is not FDA-approved and not commercially available. Prior Neuralink participants Noland Arbaugh (PRIME P1), Alex (PRIME P2), and Brad Smith (PRIME first ALS participant) are on the motor decoding track. Brad Smith's earlier speech restoration used cursor-typed text through a cloned voice; Terry's demonstration is the first Neuralink disclosure of direct neural-to-audio decoding. Neuralink has not published words-per-minute, word-error-rate, latency, or vocabulary-size metrics. No peer-reviewed methods paper accompanies the demonstration.

Sep 23

Industry News

Science Corporation names Darius Shahida President as PRIMA retinal implant enters commercial rollout

Science Corporation, Max Hodak's Alameda-headquartered neural engineering and brain-computer interface company, announced on 17 September 2026 that Chief Strategy Officer Darius Shahida has been appointed President in a dual role. Shahida joined full-time in January 2026 as CSO after eight years at Butterfly Network and after first participating in Science's Series B as an investor. He is the second senior Butterfly Network alumnus hired by Science this year; Nevada Sanchez, a Butterfly Network co-founder, joined as EVP Engineering on 29 July 2026. The Shahida appointment lands two months into the European commercial rollout of PRIMA, Science's photovoltaic subretinal implant for geographic atrophy in age-related macular degeneration, which received CE mark from DEKRA in July 2026 (30 European countries; commercial launch also covers the UK) and simultaneous FDA Breakthrough Device and Humanitarian Use Device designations. Science closed a $230 million Series C on 5 March 2026 from Khosla Ventures, Lightspeed, Y Combinator, IQT, Quiet Capital and others, bringing total capital raised to roughly $490 million since founding in 2021. Hodak remains CEO. The company operates from Alameda with offices in Paris and Research Triangle Park.

Sep 19