US consumers have OTC access a year after FDA proposed category. While OTC category is limited to devices designed for mild to moderate hearing loss and not more severe hearing impairment, it covers vast majority of consumers with hearing loss.
As of Monday 17 October, American adults with mild to moderate hearing loss will be able to walk into their local drugstore and pick up a pair of hearing aids without a prescription or prior medical exam.
This is the first time the devices will be available for direct over-the-counter purchase at retail outlets such as Walgreens, which recently announced the devices will be on shelves at...
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.
