News

Our previous Question of the Month focused on 3D printers. We asked if you thought their proliferation will negatively impact rapid prototype manufacturers. Responses were split 50-50. Here are a couple of sample responses, with more to come.

Here is the latest batch of news from the medical products community. Please click the link for more.

The application period for the National Space Biomedical Research Institute's (NSBRI) Postdoctoral Fellowship Program is now open. The two-year fellowships are available in any US laboratory carrying out space-related biomedical or biotechnological research. Applicants are required to submit...

The U.S. Food and Drug Administration (FDA) issued draft recommendations to medical product manufacturers for providing consumers with more accurate information about products not made with natural rubber latex (NRL), which can cause sensitivity or allergy in users.

The Human Connectome Project, a five-year project to link brain connectivity to human behavior, has released a set of high-quality imaging and behavioral data to the scientific community. The project has two major goals: to collect vast amounts of data using advanced brain imaging methods on a large...

Here is the latest batch of news from the medical products community. Please click the link for more.

In addition to the Chemicals Regulation REACH (Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemical substances), medical devices will soon have to comply with the European RoHS (Restriction of Hazardous Substances) Directive on the restriction of the...

Do you think the increased availability and lowered costs of 3D printers will take significant business away from rapid prototype manufacturers?

The FDA has proposed amending its regulations on acceptance of data from clinical studies for medical devices. The agency is proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a 510(k)...

Here is the latest batch of news from the medical products community. Please click the link for more.

The U.S. Food and Drug Administration is seeking input from industry and the public on the effects of extreme weather and natural disasters on the production and supply of medical devices. The FDA will use the information to identify steps that the agency, manufacturers, and the public...

The Florida State University, Tallahassee, and its High-Performance Materials Institute are leading a major partnership to develop the next generation of prosthetic limbs for military-veteran amputee patients, thanks to a new contract with the U.S. Department of Veterans Affairs. The two-year,...

The Pew Research Center, a nonpartisan fact tank that informs the public about the issues, attitudes, and trends shaping America and the world, issued a report finding that only about seven percent of people surveyed used a smartphone app to track a health indicator like weight, diet, exercise routine, or to monitor a...

Here is the latest batch of news from the medical products community. Please click the link for more.

Do you find that social media networking groups, like the Medical Devices Group on LinkedIn.com, are a viable place to discuss resources, approval processes, hiring, and more? If so, how do you verify the information provided?

Tucked within the Affordable Care Act is a provision requiring insurance companies to cover breast pumps. Insurers must pay for the new benefit, but the law doesn’t specify whether insurers must cover certain brands or types of breast pumps. It directs health plans to pay for “the costs of...

The Food and Drug Administration published a final rule governing Current Good Manufacturing Practice (CGMP) requirements for combination products, that is products that combine devices, drugs and/or biologics, usually regulated by separate FDA divisions. This rule is intended to provide clarification...

According to Jonathan Linkous, CEO of The American Telemedicine Association (ATA), Washington, DC, after 40-plus years of development, telemedicine is finally becoming mainstream in transforming the delivery of care. He said that more than five million Americans had their medical images read remotely...

Here is the latest batch of news from the medical products community. Please click the link for more.

The inaugural Patient Safety Science & Technology Summit, held this week in Laguna Niguel, CA, made history when, for the first time, nine leading medical device companies publicly pledged to make their devices interoperable.

Happy New Year! Here is the latest batch of news from the medical products community. Please click the link for more.

Some of the most innovative products realized in 2012 included an explosion of mobile healthcare apps, rapid advances in additive manufacturing, implantable robotics, bionic eyes, and more. What do you think was the most important medical product advance in 2012?

We here at Medical Design Briefs wish for a year of safety, peace, and plenty for all, and a healthy and prosperous new year for you. We are sincerely grateful for the ability to serve you and wish you the very best for the coming year. Here is the latest batch of news from the medical products community. Please...

The US Food and Drug Administration (FDA), Australian Therapeutic Foods Administration (TGA), Brazilian Health Surveillance Agency (ANVISA), and the Canadian Health Products and Food Branch (Health Canada) have all signed on to a statement of cooperation to develop a single audit program for medical...

Healthcare technology management (HTM) professionals working in hospitals say their top challenge is the management of medical devices and systems on information technology networks, according to a new survey commissioned by the Association for the Advancement of Medical Instrumentation (AAMI). The survey...

As we head into the holiday season, we want to take this opportunity to let you know how much we appreciate you, and to wish you every happiness at this festive time and throughout the coming New Year. Here is the latest batch of news from the medical products community. Please click the link for more.

More than 80 percent of US consumers and, even more surprising, more than 60 percent of Chinese consumers say that they are willing to pay more for products labeled “Made in USA” than for those labeled “Made in China,” according to new research released by The Boston Consulting Group (BCG), a global...

Today, the U.S. Food and Drug Administration announced that it is part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices. The new Medical Device...

The US Food and Drug Administration released an amendment seeking to speed the deadlines for establishing a unique device identification (UDI) system, or numeric or alphanumeric code on certain medical devices. Specifically, the amendment would apply to “implantable, life-supporting, and life-sustaining”...