Tag: FDA

11 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

Industry News

ANEUVO's spinal stimulator clears the FDA

The ExaStim system — a transcutaneous spinal cord stimulator for people with chronic spinal cord injury — has received FDA 510(k) clearance, making it the first device of its kind cleared for both clinical and home use in the United States.

Apr 16

Industry News

Phantom Neuro gets green light for first human trial of its subcutaneous prosthetic sensor

The Melbourne-based startup has received FDA approval to begin a first-in-human study of Phantom X, an implanted sensor array that reads neuromuscular signals from a residual limb without entering the nervous system — aiming to give amputees more natural prosthetic control.

Apr 15

Industry News

Paradromics Begins Recruiting Patients for Connexus Speech-Restoration Trial

The Austin-based company is now enrolling participants at the University of Michigan and Massachusetts General Hospital for the Connect-One study, the first clinical trial of a fully implantable BCI designed to restore speech.

Mar 31

Industry News

Nia Therapeutics Wins FDA Breakthrough Designation for AI-Guided Memory Implant

The Pennsylvania company's 60-channel Smart Neurostimulation System is the first device to receive Breakthrough Device Designation for TBI-related memory loss.

Mar 24

Market Moves

Cleveland Startup Sells $350 Brain Stimulation Headset Without FDA Clearance While Clinical Trials Continue

U: The Mind Company began taking orders for a consumer neuromodulation device on March 18, marketing bold clinical claims that have not appeared in peer-reviewed literature. An FDA submission is planned for 2027.

Mar 23

Industry News

Flow Neuroscience Brings First FDA-Approved At-Home Brain Stimulation for Depression to US Market

The Swedish company's FL-100 headset, cleared via the FDA's most stringent PMA pathway, launches in the US in Q2 2026 after a 174-person Nature Medicine trial. A second device, Neurolief's ProlivRx, was approved weeks later.

Mar 23

Policy & Regulation

FDA's One-Trial Default Lands Just as BCI Companies Approach Pivotal Studies

The agency's new policy ending the two-trial requirement was written for drugs, but brain implant makers watching Synchron, Neuralink, and Paradromics navigate FDA are asking whether the same logic could eventually ease their path.

Mar 22

Policy & Regulation

Medicare Has No Plan for Brain-Computer Interfaces

A Health Affairs analysis argues that CMS needs a dedicated coverage pathway for implantable BCIs before the technology outpaces the reimbursement system that patients depend on.

Mar 21

Industry News

Belgian Startup ReVision Implant Wins FDA Breakthrough Status for Visual BCI

The Leuven-based neurotech company's Occular system, which uses thousands of micro-electrodes implanted in the visual cortex to restore functional sight, has received FDA Breakthrough Device Designation.

Mar 16

Industry News

Neuralink Clears Major Hurdle: FDA Approves Expanded Clinical Trial Enrollment

FDA grants approval for Neuralink to enroll significantly more participants in its brain-computer interface clinical trials, marking a major step toward commercialization.

Feb 28

Stay Ahead of the Curve

Get the latest BCI news, breakthroughs, and market moves delivered to your inbox.

No spam. One-click unsubscribe. We respect your privacy.