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.
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By Christopher Leptak MD PhD – To be most effective, electronic health records use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care.
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 Richard Pazdur MD – One year ago, Jan. 19, 2017, FDA officially launched the Oncology Center of Excellence to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices (including diagnostics).
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 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 Kathryn O’Callaghan & Jeffrey Shuren MD – Imagine checking your blood sugar levels several times a day with a glucose meter to keep your diabetes under control. Or maybe you’ve had a hip joint replaced or a stent inserted in your coronary artery to treat a heart blockage.
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.