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On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter to RightEye, LLC (RightEye), the manufacturer of the RightEye Vision System, for misbranding...
/PRNewswire/ -- The "Brain Monitoring: Global Market Outlook" report has been added to ResearchAndMarkets.com's offering. In this report, the market has been...
The Medicines and Healthcare products Regulatory Agency (the MHRA) consulted on proposed changes to the UK’s regul…
The FDA has issued two separate draft guidance documents for medical devices being marketed subject to 1) an Emergency Use Authorization and 2) enforcement discretion ...
FDA’s Center for Devices and Radiological Health has published two draft guidance documents in anticipation of the end of the public health emergency brought about by the COVID-19 pandemic. Devices subject to the guidances should consider reviewing these documents carefully.