The Food & Drug Administration issued guidance for the medical device industry on the engagement of end user perspectives when designing and conducting clinical trials. This guidance is the product of many discussions on the impact that such perspectives have on medical device adoption by end users. Read the full guidance document on the FDA's website.
US FDA Advisement on End User Engagement
March 23, 2022
New Neuroengineering & BCI Initiative
March 15, 2022
Faculty from the University of Alabama Birmingham School of Engineering and the departments of Neurobiology, Neurology and Neurosurgery in the Heersink School of Medicine have come together to establish the UAB Neuroengineering and Brain-Computer Interface Initiative. Read the announcement via UAB.
Paralysed Man Walks Thanks to Implant
February 14, 2022
A spinal implant has allowed a paralyzed man to walk freely again. The research has been published in the journal Nature Medicine from a team of researchers in Lausanne. It is the first time someone who has had a complete cut to their spinal cord has been able to walk freely. Read the full article from the BBC.
2021 Year in Review from Neurotech Reports
February 3, 2022
Neurotech Reports editor James Cavuoto offers a concise review of 2021 accomplishments in the industry, including funding, FDA breakthrough designations, and trends to expect in 2022. Read the free article at Neurotech Reports.
Study on Bionic Vision Technology Paves the Way Towards Human Trials
January 18, 2022
The Phoenix99 Bionic Eye is an implantable system designed to restore a form of vision in persons who are blind. The device’s two main components which need to be implanted consist of a stimulator attached to the eye and a communication module positioned under the skin behind the ear. Sheep trials showed that the body accepted both these elements and furthermore healed around them. The team is now applying for ethics approval to perform clinical trials in human patients. Phoenix99 Bionic Eye Trials.
New Synthetic AI Data May Improve Brain-Computer Interfaces
November 30, 2021
Artificial Intelligence (AI) and machine learning are used in brain-computer interfaces (BCIs) to help improve how the system interprets brain activity. A new study published in Nature Biomedical Engineering by researchers at the University of Southern California (USC) apply deepfake AI technology in order to improve the performance of brain-computer interfaces to help those with speech impairment or mobility issues. AI Data for Brain-Computer Interfaces (BCI).
Blackrock Neurotech's MoveAgain System Gains FDA Breakthrough Designation
November 30, 2021
Blackrock Neurotech announced FDA breakthrough device designation for its MoveAgain brain-computer interface system. The MoveAgain system is portable and would allow persons with physical disabilities to gain mobility and independence. Read more via MassDevice.com.
Involving Children in Designing Neurotechnology
November 17, 2021
In designing neurotechnology for children with disabilities, one size never fits all. MED-EL's Ideas4Ears invites children to submit their inventions to improve the quality of life for persons with hearing loss. Children between six and twelve years old are encouraged to submit their inventions with the help of a family member. Read more about MED-EL's Ideas4Ears here.
Join NeuroAbilities as we examine how to design brain-computer interfaces by and with children with severe physical disabilities at our upcoming webinar, "BCI At Play: How Brain-Computer Interfaces can Enrich Lives of Children with Severe Physical Disability" on December 2, 2021 at 2:00 PM Eastern Time (US and Canada). Read more here.
Scientists Create Brain Implant that Enables Identification of Letters
November 10, 2021
A group of researchers in Spain collaborated with scientists at the Netherlands Institute for Neuroscience in Amsterdam and the University of Utah in Salt Lake City, US, to use a microelectrode array to help a blind person perceive letters and shapes. The implant, which is about the size of a penny, bypasses the optic nerve and instead provides stimulation to the brain’s visual cortex. By the end of the study, the participant could identify several letters. Although the device is in the early stages of clinical development, the first experiment in a human participant was successful. The results now appear in The Journal of Clinical Investigation. Read more via Medical News Today.
M-Enabling Walk2Walk Challenge
November 8, 2021
Join the Global Walk2Walk Challenge! Launched at the 2021 M-Enabling Summit, the Walk2Walk Challenge is an international set of events building a community of individuals helping those with paralysis walk using innovative walking technologies. Sandy Hanebrink, an exoskeleton user and NeuroAbilities Advisory Council member, demonstrated how access to cutting-edge exoskeleton technology creates impact in the daily lives of persons with disabilities as she stood up from her wheelchair in front of audiences at the in-person M-Enabling Summit. Individuals can register as an individual or as a team to log steps and miles. Registration deadline: 31 Dec 2021. Learn more about the Walk2Walk campaign.