Top 5 Medical Device News Posts: July 23 to 29, 2014

medical device news logoEach week, KMC Systems brings you the top 5 medical device news articles to keep you up-to-date on the latest medical device development, design and manufacturing industry information.

This is a big week for medical innovation as Brigham and Women’s Hospital scientists develop a bioreactor-on-a-chip that can revolutionize worldwide blood transfusions and sonification developments make non-invasive, on-the-spot cancer diagnosis a possibility.

Also, discover what you need to know about the EU’s proposed IVD regulation, get access to the FDA’s medical device recall data and learn from medical device entrepreneurs.


Bioreactor-on-a-chip could help meet growing need for blood transfusions worldwide

Scientists at Brigham and Women's Hospital (BWH) have developed a scalable, next-generation platelet bioreactor to generate fully functional human platelets in vitro. The work is a major biomedical advancement that will help address blood transfusion needs worldwide.

Read more on Medical News Today.


What the EU’s Proposed IVD Regulation Means for You

By Karen Hill

The proposed in vitro diagnostic (IVD) device regulation is substantially different from the current directive, and includes revised classification rules and evaluation requirements. And the sheer volume of the proposed amendments—a total of 194 pages, including 97 articles and 16 annexes—may initially appear overwhelming to many manufacturers, particularly in comparison to the current 43-page IVD Directive. So, where and how should IVD manufacturers direct their attention?

Read more on Medical Device and Diagnostic Industry (MDDI).


Insights from Medical Device Entrepreneurs

By Christina Hernandez Sherwood

Medical device entrepreneurs are pioneers who tend to be early adopters of methodologies more typically seen in other sectors. But they also face unique challenges, including in the regulatory environment.



OpenFDA Provides Ready Access to Recall Data

By Taha A. Kass-Hout, M.D., M.S.

Every year, hundreds of human and animal foods, drugs, and medical devices are recalled from the market by manufacturers. These products may be labeled incorrectly or might pose health or safety issues. Most recalls are voluntary; in some cases they may be ordered by the U.S. Food and Drug Administration. Recalls are reported to the FDA, and compiled into its Recall Enterprise System, or RES. Every week, the FDA releases an enforcement report that catalogues these recalls. And now, for the first time, there is an Application Programming Interface (API) that offers developers and researchers direct access to all of the drug, device, and food enforcement reports, dating back to 2004.

Read more on FDA Voice.


Could data sonification deliver while-you-wait cancer diagnosis?

Converting stem cell data into sounds could enable GPs to make instant, non-invasive cancer diagnoses during a routine check-up. With waiting times for cancer tests at a six-year high, this could significantly reduce the agonising and potentially life-threatening wait for patients and improve Government waiting time targets.*

Read more on Medical News Today.

Share your thoughts on any of these articles in the comments below.


Topics: KMC Systems, medical device news, medical device industry news, KMC, medical innovations