We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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.
Florida-based medical device specification developer KL Distributing was handed a Form 483 for inadequate purchasing controls, training, medical device reporting (MDR) and other lapses.
Modulight’s ML6710i photodynamic laser for use with Bauch + Lomb’s Visudyne (verteporfin) for the treatment of age-related macular degeneration (AMD) may help fill an unmet medical need, the companies said.
Companies can find it challenging to figure out the most efficient and compliant method to bring new medical devices to the U.S. market. A thorough understanding of the nuances involved in FDA regulation of new devices is necessary for companies to successfully launch new products in the U.S. without regulatory complications. Both regulatory and business factors must be considered.