News

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

All interested parties are welcome to join in the development of a proposed new ASTM International standard that will provide guidance on how to conduct axial, bending, and torsional fatigue testing of stents. The proposed new standard, ASTM WK23330, Guide for in vitro Axial, Bending and...

Five young scientists have received First Award Fellowships from the National Space Biomedical Research Institute (NSBRI). Through this two-year program, they will conduct biomedical research with the aim of helping to protect astronaut health during long-duration spaceflights. In addition to...

Today, the FDA issued its final rule on the unique device identification (UDI) system that, once implemented, will provide a consistent way to identify medical devices. The UDI system should improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more...

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

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

The Center for Internet Security (CIS), East Greenbush, NY, announced a new initiative to help bolster the protection of Internet-enabled medical devices from cyber attacks. CIS, a nonprofit organization focused on enhancing cyber security readiness and response, issued a request for...

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

The FDA Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Center for Biologics Evaluation and Research issued a Guidance document on “Radio Frequency Wireless Technology in Medical Devices” containing recommendations to assist industry and...

Medtronic, Minneapolis, MN, has entered into an innovative partnership with Center for Bioengineering Innovation and Design (CBID) at the The Johns Hopkins University, Baltimore, MD, agreeing to provide $200,000 a year for up to three years and skilled mentoring to help...

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

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

On July 9, the FDA issued a draft guidance on manufacturers’ responsibility to report adverse effects from their products: “Medical Device Reporting for Manufacturers,” for the purpose of seeking comments. Comments and suggestions should be submitted regarding this draft...

June’s Question of the Month focused on regulation of healthcare/lifestyle smartphone apps. Since regulation of some medical apps may be covered by the FDA, we asked if you thought lifestyle apps, such as pedometers and personal health records, should be regulated, and if so, by which agency. Answers were mixed,...

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

The National Collegiate Inventors and Innovators Alliance announced the winners of its annual Biomedical Engineering Innovations, Design, and Entrepreneurship Awards (BMEidea) during the MD&M East Medical Device Trade Show and Convention in Philadelphia.

On June 13, the FDA issued a safety communication on Cybersecurity for Medical Devices and Hospital Networks, which stipulated that “medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to...

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

Today, the U.S. Supreme Court unanimously invalidated patents on two genes associated with hereditary breast and ovarian cancer in response to a lawsuit filed by the American Civil Liberties Union and the Public Patent Foundation (PUBPAT) on behalf of researchers, genetic counselors, patients,...

Indiana Governor Mike Pence joined state-based global life sciences and research university executives to unveil the Indiana Biosciences Research Institute, the first industry-led collaborative life sciences research institute in the country. The Indiana Biosciences Research Institute is...

May’s Question of the Month focused on regulation of healthcare/lifestyle smartphone apps. Since regulation of some medical apps may be covered by the FDA, we asked if you thought lifestyle apps, such as pedometers and personal health records, should be regulated, and if so, by which agency. Answers were mixed, running...

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

According to a report by AlixPartners, a business advisory firm, America is becoming more competitive in terms of manufacturing and will match China on the cost of manufacturing within two years. Their research reveals that, according to current trends such as wage inflation in China and exchange...

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

The National Institute of Standards and Technology (NIST) has introduced a long-awaited measurement tool to help device designers, manufacturers, and customers to see eye to eye on eight dimensional and material property measurements that are key to device performance. MEMS, once considered a stepchild of the...

April’s Question of the Month focused on regulation of healthcare/lifestyle smartphone apps. Since regulation of some medical apps may be covered by the FDA, we asked if you thought lifestyle apps, such as pedometers and personal health records, should be regulated, and if so, by which agency. Answers were mixed,...

According to a recent report from ABI Research, a market intelligence company specializing in global technology markets, while the market for disposable wireless Medical Body Area Network (MBAN) sensors within professional healthcare is in its earliest stages, the foundations to support adoption are...

The American Orthotic & Prosthetic Association (AOPA) launched its "Coalition to Walk and Run Again," an effort to aid uninsured and under-insured victims of the April 15th Boston Marathon terror attack. The bombing killed 3 people and left more than 200 injured, several of...

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