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.
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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).
By Suzanne Schwartz MD MBA – Virtually every aspect of our lives – including our health – has gone digital. Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected and, like computers and the networks they operate in, can be vulnerable to security breaches.
By Bakul Patel – Imagine an intensive care unit for newborns. An interface on a device called a pulse oximeter is sending data on changes in the newborns’ blood oxygen level to a hospital computer system that simultaneously gathers data from EKGs that are monitoring the electrical activity of their hearts.
By Scott Gottlieb MD – When people think about personalized medicine, they often think of genetic testing and sequencing of the human genome. But the concept of personalized medicine is much broader. It includes the re-imagination of healthcare delivery.
By Sarianne Gruber – More and more medical devices are becoming smarter, and close to 15% are already smart and are on the network. The challenge with connected ‘smart’ medical devices is their vulnerability to cybersecurity attacks.
By Sarianne Gruber – More and more medical devices are becoming smarter, and close to 15% are already smart and are on the network. The…