Tag: Issue-01

9 articles

Market Moves

Precision Neuroscience closes oversubscribed $250 million Series D co-led by Pershing Square and the Ackman Oxman Institute

New York-headquartered invasive brain-computer interface operator Precision Neuroscience closed a $250 million oversubscribed Series D on Thursday 24 September 2026. Three co-leads: Pershing Square (Bill Ackman's investment firm), the Ackman Oxman Institute (the philanthropic BCI-and-neurotechnology venture Bill Ackman and Neri Oxman announced in August 2026 after their daughter Lucy's brain hemorrhage), and an undisclosed leading life-sciences investment fund. Additional participation from Duquesne Family Office (Stanley Druckenmiller), B Capital, ARK Invest, Invus, Mubadala Capital, Mirae Asset Capital, Korea Investment Partners, Hitachi Ventures, JSL Health Capital, and others. Total capital raised since 2021 founding is now $430 million. Proceeds will expand the clinical programme, advance Layer 7 through the next stages of FDA review, and build the infrastructure required for commercialisation. Precision was founded in 2021 by Ben Rapoport (Neuralink founding-team scientist, left Neuralink in 2018, Mount Sinai neurosurgeon), Michael Mager (CEO), Demetrios Papageorgiou, and Mark Hettick. Layer 7 is a thin-film 4,096-electrode microelectrode array that conforms to the cortical surface, non-penetrating, safely removable. Layer 7 holds an FDA 510(k) clearance authorising commercial use for recording, monitoring, and stimulating on the cortical surface for implantation durations of up to thirty days (granted April 2025), and has been used across 100-plus patient procedures at 18 medical institutions including the University of Pennsylvania Perelman, University of Chicago Medicine, Mount Sinai, and WVU Rockefeller Neuroscience Institute. Precision runs a wholly-owned MEMS manufacturing facility in Texas and holds a Medtronic commercial partnership. BrainGate founder and 2026 Queen Elizabeth Prize for Engineering laureate John Donoghue joined as Scientific Advisor on 23 July 2026. The Series D closes two days after Chinese non-invasive BCI operator BCI-Sonics closed a HongShan and Yunqi Partners-led RMB 200 million Pre-A in Shanghai on 22 September, the same day Premier Li Qiang inspected brain-computer interface products in Shanghai. Two top-tier private-capital signals into invasive and non-invasive brain-computer interface operators, one on each side of the Pacific, inside a single week.

Sep 25

Market Moves

BCI-Sonics closes RMB 200 million Pre-A led by HongShan and Yunqi Partners

Shanghai-headquartered non-invasive brain-computer interface company BCI-Sonics closed a RMB 200 million (~USD 28 million) Pre-A financing round on Tuesday 22 September 2026, co-led by HongShan (the post-2023 rebrand of Sequoia China under Neil Shen) and Yunqi Partners. New participants included Proxima Capital, Oriza Holdings, Shanghai's Xuhui Sci-Tech Innovation Investment, and Moral Stone Investment. Existing investors Matrix Partners China (MPCi) and Delian Capital followed on. Xunguang Capital served as exclusive financial advisor. Total capital raised since 2025 founding is roughly RMB 300 million. The company was founded by Dr. Li Xin, formerly Head of GE Global Research Center China and a joint PhD graduate of the Chinese Academy of Sciences and Fraunhofer IGD in Germany. BCI-Sonics' modality is low-intensity transcranial focused ultrasound (tFUS/LIFU) for brain stimulation, paired with a multimodal reading system combining functional ultrasound (fUS), EEG, fMRI and PET, and passive cavitation detection for safety monitoring. Three product lines are in development: a Research toolchain for neuroscience labs (unveiled at CNS 2026 in September), a Clinical portfolio targeting pain, Parkinson's, Alzheimer's, addiction, sleep, and ultrasound-mediated blood-brain-barrier opening for CNS drug delivery, and a Technology/Consumer wearable BCI terminal for sleep, focus and emotion. Closed-loop ultrasound BCI clinical trials are scheduled to enter Q1 2027. The Pre-A closed the same day Premier Li Qiang inspected BCI products in Shanghai and directed the establishment of future-industry investment-growth and risk-sharing mechanisms and 'patient capital' (耐心资本) expansion.

Sep 24

Policy & Regulation

Chinese Premier Li Qiang publicly names brain-computer interfaces a 'blue ocean' on a Shanghai inspection tour

China's Premier Li Qiang, a member of the Politburo Standing Committee, spent Tuesday 22 September 2026 on a Shanghai inspection tour of two innovation venues. At the second, the Shanghai Future Kick-off Community (上海未来启点社区) sci-tech innovation and incubation platform for future industries, he inspected technology products in two named categories: brain-computer interfaces and quantum computing. He then framed future industries as 'a potential blue ocean for advanced manufacturing' (先进制造业发展的潜在蓝海). Shanghai Party Secretary Chen Jining and State Council Secretary-General Wu Zhenglong accompanied the tour. The remarks operationalise General Secretary Xi Jinping's prior directive on advanced manufacturing and the spirit of the National Conference on Advanced Manufacturing. The visit lands Li Qiang's on-record inspection of BCI products above the March 2025 Government Work Report first-mention (re-named March 2026), above the 15th Five-Year Plan naming of BCI as a future industry (CPC 4th Plenum, 20 to 23 October 2025), and above the seven-ministry BCI Implementation Opinions of 20 July 2025. The venue itself is not disclosed to have featured named Chinese BCI operators. Shanghai's Minhang District already hosts the country's first BCI industry cluster at Brain Intelligence World, which by mid-2026 housed 61 BCI companies, roughly 30 percent of the national BCI operator field.

Sep 23

Policy & Regulation

China issues a medical-device standard for AI processing of EEG data in brain-computer interfaces

China's National Medical Products Administration (NMPA) has issued what state news agency Xinhua characterises as the world's first medical-device standard covering AI-processed electroencephalogram (EEG) data in brain-computer interfaces, announced on 14 September 2026. The standard was drafted by the National Institutes for Food and Drug Control (NIFDC) under an expedited procedure and becomes effective on 1 September 2027. Scope: quality requirements and evaluation methods for EEG datasets used by AI algorithms in BCI medical devices, covering collection, processing, annotation, storage, and access across R&D, production, and quality-control stages. Named NMPA and NIFDC officials: Yuan Peng (Deputy Director, NMPA Department of Medical Device Registration), Li Shu (Deputy Director, NIFDC medical device institute), Zheng Jia (Deputy Director, NIFDC Institute for Medical Device Standardization). This is the third BCI-related medical-device standard issued by China in twelve months, following 2025 standards on BCI terminology and on test methods for implantable closed-loop neural stimulators. The US FDA has no BCI-specific AI/EEG data-quality standard. The EU has no BCI-specific standard, only horizontal AI Act coverage of medical BCI as high-risk. On the narrow AI-EEG-BCI slice, China's world-first framing holds up.

Sep 17

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

Policy & Regulation

Cambridge-led security team names five attack families that break AI-powered brain-computer interfaces

A team led by Zahra Tarkhani (Microsoft), Georgios Akkogiounoglou (KTH Royal Institute of Technology), Lorena Qendro (Nokia Bell Labs), Isabel Tscherniak (TU Munich), and senior author Anil Madhavapeddy (University of Cambridge) published NERVE Attacks: Breaking AI-Powered Brain-Computer Interfaces on arXiv on 8 September 2026. The paper introduces a taxonomy of five attack families that together span the complete BCI signal chain: Neuro-mimetic Forgery, Evasion via Desynchronization, Replay-based Hijacking, Vein Tapping, and Embedded Backdoors. It releases EEGle, an AI-assisted extensible framework for systematic BCI security analysis, and reports 17 novel neuro-specific attack instances plus a stealth-effectiveness spectrum for BCI backdoor design. The submission lands four days after Germany's outgoing federal data protection commissioner used the BfDI's annual Bonn conference on 4 September 2026 to press for tighter European handling of neurodata, and one day after four senior clinician-scientists published a Comment in Nature Neuroscience setting out four ethical priorities for implantable BCI research. The empirical attack surface has now caught up with the governance framing.

Sep 13

Market Moves

ONWARD Medical crosses seven ARC-BCI implants as ARC-EX commercial revenue grows 240 percent in H1

Dutch-Swiss neurotech ONWARD Medical (Euronext ONWD) reported First Half 2026 results on 9 September 2026 with total revenue of EUR 4.2 million (up from EUR 1.2 million H1 2025), ARC-EX external spinal-stimulator commercial revenue up 240 percent to EUR 3.4 million, and cumulative ARC-BCI Therapy participants now at seven, with two additional implants completed in the half. ARC-BCI is ONWARD's flagship platform pairing the CEA/Clinatec WIMAGINE 64-electrode epidural cortical brain-computer interface (exclusive-licensed 15 October 2024) with the ARC-IM implantable spinal cord stimulator. ONWARD is accepted into the FDA Total Product Life Cycle Advisory Program for ARC-BCI. Cash position was EUR 81.5 million at 30 June 2026 following the April 2026 EUR 40.6 million equity raise led by EQT Life Sciences and a new BlackRock debt facility up to EUR 50 million. ARC-EX (FDA De Novo cleared December 2024) is now available in more than 130 US clinics and shipped 159 systems in the half.

Sep 10

Policy & Regulation

Four senior BCI neurosurgeon-scientists use Nature Neuroscience to press for tighter research ethics as implant numbers scale

Four clinician-scientists from Mayo Clinic, University College London, and Sichuan University published a Comment in Nature Neuroscience on 7 September 2026 setting out four ethical priorities for implantable brain-computer interface research: separating research participation from patient care, ensuring long-term support for study participants, avoiding disproportionate risks to participants for benefits realised mainly by others, and grounding research in meaningful clinical purpose. Lead author Kai J. Miller (Mayo Clinic) is the corresponding author. Senior author Gerwin Schalk (West China Hospital, Sichuan University) is the second corresponding author. Co-author Harith Akram (UCL Queen Square) declares a conflict of interest as Chief Investigator of Neuralink's GB-PRIME UK study. The Comment lands one day after Germany's outgoing federal data protection commissioner pressed Europe for tighter rules on bidirectional BCI, and ten months after UNESCO's General Conference adopted the first global standard on the ethics of neurotechnology in November 2025.

Sep 8

Policy & Regulation

Germany's data protection commissioner presses Europe for tighter rules on bidirectional brain-computer interfaces

Prof. Dr. Louisa Specht-Riemenschneider, the outgoing German Federal Data Protection and Freedom of Information Commissioner (BfDI), used a BCI-themed academic conference at the University of Bonn on 4 September 2026 to press for tighter European handling of neural data. Her formal underpinning is a Berlin Group Working Paper on Emerging Neurotechnologies published on 15 May 2025 through BfDI, which invokes GDPR Article 9 (health and biometric data) and the EU AI Act (Article 5 subliminal-manipulation ban, Annex III high-risk classification for medical BCI) as existing legal ground. The intervention lands one month before Specht-Riemenschneider steps down for health reasons on 30 September 2026. Her Bundestag-elected successor Prof. Dr. Moritz Hennemann of Freiburg takes office on 1 October 2026, and his own position on neurodata is not publicly disclosed.

Sep 6