By Stephen M. Hahn MD – One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections.
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New On Demand Dr. Nick: The Incrementalist: With guest Jeremy Elias, Founder & CEO of TrackMy Solutions, a company taking on the challenge of keeping track of all the devices and technology.
By Christina Jewett – FDA Commissioner Scott Gottlieb announced in a tweet recently that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.
By Scott Gottlieb MD – Advancing the public health means helping to make sure patients have access to safe, effective medical products. Access is a matter of public health. And our commitments to patients don’t stop at the time of a product’s approval.
By Stephanie Crabb – A recent announcement in Becker’s (Jackson Health Signs Patient Monitoring Deal with Philips) seems to be pointing to an emerging trend in innovative and transformative business models between medical device manufacturers and providers.
By Scott Gottlieb MD – Over time, as our experience with new medical products expands, our knowledge about how best to maximize their benefits and minimize any potential risks, sharpens with each data point we gather.
By Gerry Blass – Medical device cybersecurity has become significantly more important in the age of digital health. There are essential actions health systems must take to protect themselves – and their patients.
By William A. Hyman – It has long been clear that the FDA can regulate software that falls under the definition of a medical device. Such software might be part of and integral to a more physical chunk of technology.
By Waqaas Al-Siddiq – Today’s technology landscape is defined by the convergence of the Cloud, Big Data, new software platforms, and smart devices. Together, they form a web of connections that determine the amount of data that we collect and the way we use it.