Ann Cleland’s picture

By: Ann Cleland

If your hospital or clinic uses a Windows 7-based version of a Siemens PET/CT or SPECT system, it could be vulnerable to attack by a relatively low-skill hacker, according to a July 26, 2017, security advisory from the company.

Anna Abram’s picture

By: Anna Abram

We’re at a moment of extraordinary opportunity to improve public health. New innovations are giving us fundamentally better ways to address disease. Some of the same technology is providing consumers with a broader selection of foods that can improve peoples’ diets and products that can expand their choices. At the same time, we also face a lot of new challenges. The steps FDA takes to advance these opportunities, and address uncertainties, will directly affect the lives of families.

Richard Pazdur’s picture

By: Richard Pazdur

When I was in high school, I spent summers working as a restaurant dishwasher, grocery store stock boy, and gardener in northwest Indiana. The idea of spending those weeks learning about science and medicine would not have been an option for me at that time.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more.

“Climbing Stairs Just Got Easier With Energy-Recycling Steps”

These stairs actually help you go up.

AssurX’s picture

By: AssurX

Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.

Scott Gottlieb’s picture

By: Scott Gottlieb

It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, the FDA can promote health through the creation of more new and beneficial medical technologies.

InfinityQS’s picture

By: InfinityQS

On Jan. 1, 2017, Philadelphia became one of the first U.S. cities to pass a tax ($0.15 per oz) on sugary drinks, including artificially sweetened beverages, such as diet soda. In California, San Francisco, Albany, Berkeley, and Oakland have joined Philadelphia in this initiative, as well as Boulder, Colorado; Cook County, Illinois; and Seattle.

AssurX’s picture

By: AssurX

The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on real-world evidence (RWE).

AssurX’s picture

By: AssurX

The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.

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