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Thought-Controlled Prosthetics Get US FDA 'Leapfrog' Treatment

 
• By David Filmore

A new "leapfrog" draft guidance from the US agency addresses implanted brain-computer interface prosthetic devices, and, specifically, the information sponsors should be prepared to submit for pre-submissions meetings and investigational device exemptions.

3D X-ray of human brain with computer chip and circuit on star and galaxy background - Illustration

US FDA has been working with academic scientists, the US military and device companies for the past decade on implants that might interface with the nervous system, allowing a paralyzed patient or amputee to control a prosthetic with their thoughts. The agency recorded what it has learned from those efforts in a draft guidance posted Feb. 22 that is intended to help sponsors develop such a device to the point of entering clinical studies.

FDA's interest in the advancing field of brain-computer interface (BCI) devices has been evident at least since 2011, when it...

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FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
• By Amanda Maxwell

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

EU4Health Boost For Orphan Devices And SMEs

 
• By Ashley Yeo

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

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