View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
February 25, 2019

FDA issues draft guidance for brain-computer interface devices

The US Food and Drug Administration (FDA) has issued draft guidance to drive the development of brain-computer interface (BCI) devices, a new generation of implants that could provide users with direct control.

The US F ood and Drug Administration (F DA) has issued draft guidance to drive the development of brain-computer interface (BCI) devices, a new generation of implants that could provide users with direct control.

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

BCI devices are often used to regulate limb prosthesis. The direct control feature of these implants is expected to enable significantly more mobility and independence for patients.

The regulatory agency added that the devices possess the potential to help people living with severe disabilities by improving their ability to interact with their environment.

F DA commissioner Scott Gottlieb referred to the draft guidance as a ‘leap-frog’ guidance to help bridge current technology with future innovations.”

Recently, F DA Center for Devices and Radiological Health held a workshop focused on BCI devices, which were defined as brain implants that communicate with a patient’s nerves and muscles in order to help them gain mobility or a sense of touch.

The agency said that an outcome of the workshop was the initiation of the draft guidance, which will be open to public comment as it is finalised.

This guidance is intended to help developers, as well as maintain necessary protections for patients.

F DA commissioner Scott Gottlieb referred to the draft guidance as a ‘leap-frog’ guidance to help bridge current technology with future innovations.

Gottlieb added: “This is a critical area of development for the millions of people who suffer from conditions that inhibit their mobility. Today, we’re issuing draft guidance to help spur development of BCI devices for patients with paralysis or amputation, including our nation’s veterans.”

The draft guidance outlines recommendations for developers on non-clinical testing and clinical study design that could be leveraged to create BCI devices for patients with paralysis or amputation.

Specifically, the F DA is offering detailed technical advice and recommendations for study designs to support safety and effectiveness.

Technological developments for prosthetic limb patients are continuing to advance in other areas too. Last week, a team of Swiss and Italian researchers revealed that they had developed a bionic hand to help amputees regain their proprioception, an instant and accurate sense of the position of limbs during and after movement.

Additional reporting by Charlotte Edwards. 

Related Companies

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network