A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: ALS

BCI Developer Synchron Acquires Equity Stake in Nitinol Part Maker ACQUANDAS

Posted on by Posted in AIMD Business, ALS, Brain-Computer Interface, EEG Monitoring, Paralysis, Synchron
Synchron stent electrode

Image Credit: Synchron

Brain-computer interface (BCI) developer Synchron announced the acquisition of an equity stake in ACQUANDAS, a provider specializing in  high-precision nitinol components.

Synchron is developing endovascular technology to restore functionality in patients with motor impairment.    Synchron’s Stentrode™ is an endovascular neural interface. It is essentially an electrode array shaped as an endovascular stent that can be implanted via the jugular vein and advanced into the brain to the motor cortex. Neural signals are detected by the electrodes on the Stentrode™ and sent to a processing and communications unit implanted subcutaneously in the chest, and then wirelessly to an external receiver. The idea is that the device can interpret signals from the brain for patients with paralysis to control a computer operating system and set of applications that interact with assistive technologies.

First Human Implant of Neuralink BCI

Posted on by Posted in ALS, Brain-Computer Interface, EEG Monitoring, Neuralink, Paralysis, Spinal Cord Injury (SCI)
Neuralink implant

Image credit: Neuralink

Elon Musk posted on X that Neuralink conducted the first human implant of its brain-computer interface:

Image Capture from X

Details are scant at this time, but Neuralink announced back in September ’23 that they had started recruiting subjects with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) for their PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface), which is an IDE trial for their fully-implantable, wireless brain-computer interface (N1) and surgical robot (R1).

Neuralink Announces that First-in-Human Clinical Trial is Open for Recruitment

Posted on by Posted in ALS, Brain-Computer Interface, EEG Monitoring, Neuralink, Spinal Cord Injury (SCI)
Neuralink implant

Image credit: Neuralink

Neuralink announced that they have started recruiting subjects with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) for their PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface), which is an IDE trial for their fully-implantable, wireless brain-computer interface (N1) and surgical robot (R1).  The study will assess the initial functionality of Neuralink’s BCI for enabling people with paralysis to control external devices with their thoughts.

According to the announcement:

During the study, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention. Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention. The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone.

The PRIME Study is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023 and represents an important step in our mission to create a generalized brain interface to restore autonomy to those with unmet medical needs.

Those who have  may qualify.

First Clinical Implant of Synchron’s Stentrode® Minimally-Invasive Neural Interface

Posted on by Posted in ALS, Brain-Computer Interface, Muscular dystrophy, Spinal Cord Injury (SCI), Stroke, Synchron
Stentrode by Synchron

Image Credit: Synchron

Synchron Inc. announced today the first successful clinical implantation of the Stentrode®, a minimally-invasive neural interface technology, a component of the Synchron Brain-Computer Interface. This is the first clinical feasibility trial evaluating this technology for its potential to restore communication in people with severe paralysis.

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