A company that makes an implantable brain-computer interface (BCI) has been given the go-ahead by the Food and Drug Administration to run a clinical trial with human patients. Synchron plans to start an early feasibility study of its Stentrode implant later this year at Mount Sinai Hospital, New York with six subjects. The company said it will assess the device’s “safety and efficacy in patients with severe paralysis.” https://www.engadget.com/fda-brain-computer-interface-clinic…ml?src=rss

A company that makes an implantable has been given the go-ahead by the Food and Drug Administration to run a clinical trial with human patients. Synchron plans to start an early feasibility study of its Stentrode implant later this year at Mount Sinai Hospital, New York with six subjects. The company said it will assess the device’s “safety and efficacy in patients with severe paralysis.”

Synchron received the FDA’s green light ahead of competitors like Elon Musk’s. Before such companies can sell BCIs commercially in the US, they need to prove that the devices work and are safe. The FDA will provide guidance for trials of BCI devices for patients with paralysis or amputation during a webinar on Thursday.

Another clinical trial of Stentrode is underway in Australia. Four patients have received the implant, which is being used “for data transfer from motor cortex to control digital devices,” Synchron said. According to data published in the Journal of NeuroInterventional Surgery, two of the patients were able to control their computer with their thoughts. They completed work-related tasks, sent text messages and emails and did online banking and shopping.

The U.S. Food and Drug Administration has for the first time approved a video game for treating attention deficit hyperactivity disorder in children.

The FDA said Monday the game built by Boston-based Akili Interactive Labs can improve attention function.

The game, called EndeavorRx, requires a prescription and is designed for children ages 8 to 12 with certain symptoms of ADHD.

Research on robotic prostheses is coming along in leaps and bounds, but one hurdle is proving quite tricky to overcome: a sense of touch. Among other things, this sense helps us control our grip strength — which is vitally important when it comes to having fine motor control for handling delicate objects.

Enter a new upgrade for the LUKE Arm — named for Luke Skywalker, the Star Wars hero with a robotic hand. Prototype versions of this robotic prosthesis can be linked up to the wearer’s nerves.

And, thanks to biomedical engineers at the University of Utah, for the participants of their experimental study, the arm can now also produce an ability to feel. This spectacular advance allowed one wearer to handle grapes, peel a banana, and even feel his wife’s hand in his.

Biofeedback will also be able to help with problems that feel intractable, by conditioning students to make time to think outside the box. Studies show the best way is to deal with a seemingly intractable problem is to consider it intensely for a period of time and then to relax to an almost meditative state to foster the brain’s creative side.

We have trialled technology that can help users manage this approach in Finland, using an app called Study Train that has been designed by Finnish education experts. The app combines the Pomodoro time-management technique with customised learning rhythms based on an individual’s brain waves, telling students to focus when learning efficiency is high and to rest meditatively to promote lateral thinking and creativity when efficiency is low. It is now being used by students in China, Malaysia and Taiwan as well as in Finland and next year will be rolled out further.

We have long known that the brain has good and bad times for retaining information and solving problems. By combining EEG data and machine learning we can now we confident when those different states occur and use that information to improve students’ learning. 2019 will be the year when study becomes turbocharged.

Bionic Vision Technologies, a firm based in Australia, has announced that its bionic eye system has been used to restore a “sense of sight” to four completely blind people suffering from retinitis pigmentosa. The findings from the study, which was performed at Royal Victorian Eye and Ear Hospital in Melbourne, were presented at the Royal Australian and New Zealand College of Ophthalmologists Scientific meeting.

Unlike previous studies of the technology that were limited to in-lab use, the four patients were able to use the system in their everyday environments.

On Star Trek: The Next Generation, Commander Riker had an impressive ability to receive head wounds. Luckily for him, Dr. Crusher could whip out the “dermal regenerator,” a handheld sci-fi tool that healed skin wounds with a colorful laser.

In early tests, this laser-activated silk and gold material held wounds together better than stitches or glue.

The FDA has recently given 510(k) clearance to the OpenSight Augmented Reality System, the first augmented reality (AR) medical solution for Microsoft HoloLens cleared for use in pre-operative surgical planning.

The technology projects 2D, 3D and 4D images of patients interactively by overlaying them onto the patient’s body, according to a Novarad press release published Oct. 24.

OpenSight specifically utilizes the Microsoft HoloLens headset that allows simultaneous visualization of the 3D patient images in AR and the actual patient and their real-world surroundings. The technique may decrease operative times and improve surgical planning and the understanding of anatomic relationships.

This program lets you be a blind person’s eyes anytime from anywhere in the world.

This musician lost his arm to an electrical transformer. Now he’s become the world’s first bionic drummer.

Via Superhuman

WASHINGTON — Scientists have created a hair-thin implant that can drip medications deep into the brain by remote control and with pinpoint precision.

Tested only in animals so far, if the device pans out it could mark a new approach to treating brain diseases — potentially reducing side effects by targeting only the hard-to-reach circuits that need care.

“You could deliver things right to where you want, no matter the disease,” said Robert Langer, a professor at the Massachusetts Institute of Technology whose biomedical engineering team reported the research Wednesday.