The mobile health devices and wearables trend is seemingly accelerating this year, with 546 digital health and 635 wearable devices being touted at the annual CES show in Las Vegas. Digital health devices and wearables on display are up from the 505 and 620 devices, respectively, presented at CES 2019. Health and medical devices being […]
Electromedical Products International
FDA proposes to require PMAs for cranial electrotherapy stimulators for depression
The FDA is proposing to require manufacturers of cranial electrotherapy stimulators to submit pre-market approval applications if their devices are intended to treat depression. The federal safety watchdog said it’s also proposing to down-classify CES devices aimed at treating insomnia and anxiety from Class III, which would also require PMA applications, to Class II subject to […]