The US agency has banned the use of electrical stimulation devices (ESDs) to prevent self-injurious or aggressive behavior. The ban was first recommended at a 2014 FDA panel hearing and is widely supported by the disability community. The move by the agency is rare; it’s only the third time a medical device has been completely blocked from use in the US.
The US Food and Drug Administration took the rare step of banning a device type on 4 March, announcing that electrical stimulation devices (ESDs) to prevent self-injurious or aggressive behavior can no longer be legally used or marketed in the country.
In ESD treatment, electrodes attached to the skin deliver an electrical shock intended to discourage unwanted or dangerous behavior. They’re in use at the Judge Rotenberg Educational Center (JRC) in...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
