Medical Devices Archives - Regulatory Professionals

April 24, 2019

FDA gives green light to ADHD medical device

NeuroSigma’s prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first non-drug treatment for ADHD to be approved by the FDA and is indicated for patients aged 7 to 12 who are not taking a prescription ADHD medication. The device, which is approximately the size of a mobile phone, generates a low-level electrical pulse

Written by Kathleen McCarthy

August 31, 2016

UK Regulator Updates Guidance on Apps and Medical Devices

UK regulator, MHRA, has updated its guidance on whether a health app should be subject to medical device oversight. A variety of apps and stand-alone software that are already on the market have so far been classified as medical devices meaning that they fall within the MHRA’s remit.

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FDA gives green light to ADHD medical device

UK Regulator Updates Guidance on Apps and Medical Devices

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