• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Report: FDA says Musk’s Neuralink can go ahead with second brain implant

Report: FDA says Musk’s Neuralink can go ahead with second brain implant

May 20, 2024 By Sean Whooley

This Neuralink marketing image shows its coin-sized brain-computer interface separated into parts.
Neuralink says its brain-computer interface is fully implantable, cosmetically invisible, and designed to let a person control a computer or mobile device anywhere they go. [Image courtesy of Neuralink]
The Wall Street Journal today reported that the FDA gave Elon Musk’s Neuralink the go-ahead to conduct another brain-computer interface implant.

Neuralink’s remotely rechargeable implant goes along with electrode-laced threads that go further into the brain. The company also has an R1 robot designed to implant the BCI system while avoiding vasculature. It’s one of many companies vying for the top spot in the growing BCI space.

In September 2023, Neuralink opened up recruitment for its first-in-human clinical trial after the FDA OK’d it about a year ago. Musk said in January that the first patient received their implant, which he plans to call “Telepathy.” A nine-minute livestream demonstration showed Noland Arbaugh using the Neuralink BCI to move a computer cursor and play chess online.

However, since that first implant, Neuralink has faced scrutiny over a potential wiring issue with the BCI. The company said earlier this month that several threads retracted from the brain in the weeks following the first human implant. The retraction led to a net decrease in the number of effective electrodes and a reduction in data bits-per-second (BPS). This metric measures the speed and accuracy of the patient’s ability to use the BCI technology to control a computer mouse cursor.

Reuters then reported last week that people familiar with the matter say Neuralink knew of this issue for years, but felt it was not enough of a risk to require a redesign effort.

The WSJ report said Neuralink plans to fix the wiring issue by embedding wires deeper into the brain as it prepares for its next human implant. The FDA, according to the WSJ, said it can’t discuss or disclose information related to human clinical trial applications, but the outlet’s sources say the agency has given Neuralink the green light to conduct its next procedure.

Neuralink plans to implant the Telepathy device in a second patient next month, the report said. The company expects a total of 10 implants this year.

According to the WSJ, the company also plans to submit applications to begin trials in Canada and the UK in the coming months.

Filed Under: Brain-Computer Interface (BCI), Clinical Trials, Featured, Food & Drug Administration (FDA), Health Technology, Implants, Neurological, Regulatory/Compliance Tagged With: FDA, neuralink

More recent news

  • Medtronic escapes $106.5M payment in Colibri TAVR patent suit after court overturns jury verdict
  • RadNet closes iCAD acquisition, expands AI breast‑imaging portfolio
  • Hyperfine reports first commercial sales of next-gen AI-powered Swoop
  • Stereotaxis announces $12.5M offering
  • Nuwellis ends clinical trial of its ultrafiltration tech for heart failure

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy