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.
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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.
By Jeffrey Shuren MD, JD – Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world.
By Kayla Matthews – Options for treating patients and helping them stay healthy are rapidly evolving, and improved technology is largely responsible for making that the case. Some of the available offerings could forever change how patients and physicians interact with each other.
By Scott Gottlieb MD & Jeffrey Shuren, MD JD – Recently, the Food and Drug Administration has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.
By William Hyman – The 21st Century Cures Act addressed what kinds of medical software are medical devices (and therefore subject to regulation by the FDA), and what kinds are not medical devices (and therefore not regulated by the FDA, but subject to CPSC and FTC).