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Mammography combines “the science of imaging and the art of positioning” [1]. Although there have been many significant and exciting changes to the technology of mammography since the passage of MQSA in 1999, including the introduction of full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT), one aspect of mammography that remains unchanged and critically…

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This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Micra Transcatheter Pacing System (TPS)PMA Applicant:…

Email Digital Health Questions to the FDA Overview The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Providers and other stakeholders are using digital health in their efforts to: Reduce inefficiencies,  Improve access, Reduce costs, Increase quality, and, Make…

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The FDA is building the foundations of a national evaluation system to generate better evidence more efficiently for medical device evaluation and regulatory decision-making. A national evaluation system would generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence, and applying advanced analytics to data tailored to the…