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The FDA has sent neurovascular device company MicroVention a warning letter after the agency was not satisfied with the company’s responses to a Form 483 inspection report which noted problems with validations, correction and preventive actions, and other lapses.
The European Medicines Agency (EMA) is launching a pilot program to offer scientific advice to manufacturers of certain high-risk medical devices, to help streamline their path to market.
The Medical Device Manufacturers Association (MDMA) and AdvaMed have called for several FDA actions to streamline and simplify the agency’s Voluntary Malfunction Summary Reporting(VMSR)program.
A citizen petition filed on behalf of the Clinical Decision Support Coalition has called on the FDA to rescind its September 2022 final guidance on Clinical Decision Support Software (CDS).
The U.S. Court of Appeals for the District of Columbia has rejected petitions from a cohort of drug and devicemakers that seek to overrule a decision last year allowing to proceed a lawsuit accusing the companies of indirectly funding terrorist acts in Iraq.
Dermalyser, an artificial intelligence (AI) skin cancer diagnostic tool from Swedish start-up AI Medical Technology, diagnosed melanoma-suspected cutaneous lesions with high accuracy in a 240-patient clinical trial conducted at 37 primary care settings in Sweden.