https://howitunfolded.com/companies/neuralink/Ongoing. Trace the research platform, the first human trial, a disclosed implant setback and expansion into new studies. Company reports of participant experience are kept distinct from regulatory approval and established clinical benefit.enhttps://howitunfolded.com/companies/neuralink/#e15neuralink-7af91bcc84Thu, 29 Oct 2026 12:00:00 +0000Neuralink reported a 72-hour engineering session testing features for its Bloom speech app, including automatic start and stop detection, text editing and phone-call integration. The company described prototypes developed with one trial participant and stated that its devices remained investigational, without marketing approval from the FDA or other regulators.https://howitunfolded.com/companies/neuralink/#e14neuralink-588c80f894Thu, 01 Oct 2026 12:00:00 +0000The company described participant-specific models trained on previously collected neural recordings, reporting longer-lasting cursor control in early use. It also said that pooling data across participants had not yet improved live performance over individual models. These are sponsor-reported engineering results, not proof of general clinical benefit.https://howitunfolded.com/companies/neuralink/#e13neuralink-f278c7b41fWed, 28 Jan 2026 12:00:00 +0000Neuralink's two-year update reported 21 participants enrolled in trials worldwide and described experience with digital control and assistive devices. These were sponsor-reported observations, not a conclusion that the technology was proven safe or effective for general use.https://howitunfolded.com/companies/neuralink/#e12neuralink-13b111933eFri, 03 Oct 2025 12:00:00 +0000Neuralink's registered VOICE protocol records 3 October as the actual study start. It describes early feasibility research into initial safety and communication using the N1 implant and R1 robot. The registry entry was first posted on 4 November, after the start date.https://howitunfolded.com/companies/neuralink/#e11neuralink-cbf2738a4aThu, 31 Jul 2025 12:00:00 +0000Neuralink announced approvals for GB-PRIME and recruitment through University College London Hospitals and Newcastle upon Tyne Hospitals. The study again focused on safety and initial functionality.https://howitunfolded.com/companies/neuralink/#e10neuralink-ac31523fb3Mon, 02 Jun 2025 12:00:00 +0000The company announced a USD 650 million Series E round to support its work. A financing announcement is distinct from a regulatory assessment of the technology.https://howitunfolded.com/companies/neuralink/#e9neuralink-260a76b89dThu, 01 May 2025 12:00:00 +0000Neuralink announced FDA Breakthrough Device designation for a project intended to assist communication in people with severe speech impairment. The designation alone did not establish that the device could be marketed or that its proposed benefits had been proven.https://howitunfolded.com/companies/neuralink/#e8neuralink-04a1b735f0Sun, 24 Nov 2024 12:00:00 +0000Neuralink announced approval and launch of a feasibility study using the N1 implant with an investigational assistive robotic arm. The design allowed participants in PRIME to enrol in the additional study.https://howitunfolded.com/companies/neuralink/#e7neuralink-9b6a0a718aWed, 20 Nov 2024 12:00:00 +0000The company said Health Canada had authorised CAN-PRIME and opened recruitment. It described a study of the implant and robot's safety and initial functionality, rather than a commercial treatment launch.https://howitunfolded.com/companies/neuralink/#e6neuralink-998f029ad8Tue, 17 Sep 2024 12:00:00 +0000Neuralink announced FDA Breakthrough Device designation for its Blindsight project for people with vision impairment. The FDA explains that designation helps accelerate development and review, while separate safety and effectiveness standards still apply to marketing authorisation.https://howitunfolded.com/companies/neuralink/#e5neuralink-d4b0bc7620Wed, 21 Aug 2024 12:00:00 +0000Neuralink reported that its second participant received an implant in July. It described measures to reduce brain movement and the implant-to-brain gap, and said no thread retraction had been observed in that participant. It also said the first participant’s threads had stabilized and performance had recovered. These were company reports at that date.https://howitunfolded.com/companies/neuralink/#e4neuralink-9baa27208dWed, 08 May 2024 12:00:00 +0000The company reported that threads had retracted from the first participant's brain in the weeks after surgery, reducing the number of effective electrodes and performance. It said changes to signal processing, cursor control and the interface subsequently improved performance. This report does not establish that the underlying implant issue was eliminated.https://howitunfolded.com/companies/neuralink/#e3neuralink-71f1dbd641Mon, 01 Jan 2024 12:00:00 +0000Neuralink's April update dates its first human implant to January 2024 at Barrow Neurological Institute. It identifies neurosurgeon Francisco A. Ponce as principal investigator for the study at Barrow.https://howitunfolded.com/companies/neuralink/#e2neuralink-c3ba2ab55eTue, 19 Sep 2023 12:00:00 +0000Neuralink announced recruitment for PRIME after approval from the reviewing institutional board and its first hospital site. The study was designed to evaluate implant and surgical-robot safety and initial functionality for controlling external devices.https://howitunfolded.com/companies/neuralink/#e1neuralink-c62aa3b8a9Mon, 01 May 2023 12:00:00 +0000Neuralink's later recruitment announcement states that the FDA awarded an investigational device exemption in May 2023. The exemption concerned conducting research, rather than commercial approval of the implant.https://howitunfolded.com/companies/neuralink/#e0neuralink-d813611a74Thu, 31 Oct 2019 12:00:00 +0000A paper credited to Elon Musk and Neuralink described flexible electrode threads, a surgical insertion robot and an experimental brain-machine interface platform. This was a research publication, not evidence of an approved human treatment.