News

Our thoughts are with those who were affected by Hurricane Sandy and its aftermath. The storm's destructive force was felt across the East Coast, but none were more directly impacted than those within the tri-state area—New Jersey, New York, Connecticut. We recognize that the storm's torrential rains, powerful...

While health technology advances provide new ways to improve patient care, some may also create new opportunities for harm. To help minimize the risk of technology-related adverse events, the ECRI Institute, an independent nonprofit that researches the best approaches to improving patient care, has released its Top...

The market for microelectromechanical systems (MEMS) used as pressure sensors in medical electronics is likely to grow by 7 percent this year, aided by the use of disposable devices as well as respiratory monitoring, according to iSuppli, El Segundo, CA, a global leader in technology value chain research...

In Brussels, Belgium, the PVCMed Alliance was launched to promote the use and value of PVC in healthcare applications. PVC, or polyvinyl chloride, is the third-most widely produced plastic. The PVCMed Alliance is a coalition of PVC resin and plasticizer producers and PVC converters. The Alliance’s...

The Cleveland Clinic, a nonprofit multispecialty academic medical center in Cleveland, OH, has announced its list of Top 10 Medical Innovations that will have a major impact on improving patient care within the next year. The list is made up of devices, including a handheld optical scan for...

The US Food and Drug Administration has set new review timeframes and performance goals for 510(k) premarket notification reviews of medical devices following Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. By 2017, the agency intends to reduce the...

The long awaited proposed Regulations for Medical Devices (and active implantable medical devices) and IVDs were released by the EU Commission. A new free white paper from the Emergo Group, Austin, TX, which provides regulatory consulting, explains several detailed items in the proposed...

A newly released annual report from Ernst & Young, Pulse of the Industry, reveals that publicly traded medtech companies in the US and in Europe turned in a solid performance in 2011, with revenue growth outpacing 2010 rates and delivering a third consecutive year of double-digit net income...

Happy Halloween! Here is the latest news from the medical products community.

Today, November 8th, marks the first International Day of Radiology, marking the anniversary of the discovery by German physicist Wilhelm Roentgen in 1895 of the electromagnetic radiation in a wavelength range commonly known as X-rays. It celebrates the tremendous advances in patient care made...

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "eCopy Program for Medical Device Submissions,'' for industry and FDA staff. The purpose of the draft guidance is to explain the new electronic copy (eCopy) program for medical...

Heading into Fall, here is the latest batch of news from the medical products community. Click the link for more. Leadership News Z-Laser, Freiburg, Germany, a manufacturer of laser modules and laser projection systems, has named Stefan Randak as its new CEO. Kurt-Michael Zimmermann, founder and former managing...

Clemson University, Clemson, SC, has established the first program to train engineers to recycle and reprocess medical devices. Medical device reprocessing was identified as a core component of green technology, so in response, the university’s Biomedical Engineering Innovation Campus (CUBEInC)...

Is your company developing a medical product that could help solve a health or human performance challenge in space? Have you developed a biomedical product for the space program that could also improve health on Earth? The National Space Biomedical Research Institute’s (NSBRI) Industry...

Here is a compilation of changes in leadership, expansions, mergers, and acquisitions that have taken place in the medical device industry during the second half of September. If you have news to be included in this section, please send it to the editor, Beth Sisk, at beth@techbriefs.com.

The FDA has compiled a list of FAQs provided to assist medical device establishments with understanding the new requirements and responsibilities for registration and listing that become effective today, October 1, 2012. The information includes a list of changes to medical device listing and...

The Reshoring Initiative, whose ongoing mission is to broadcast the benefits of reshoring or bringing manufacturing jobs back to the United States, celebrated its first year of incorporation, as well as the achievement of significant national attention and support of its efforts. The number of...

It's mid-September and there have been many new leadership changes, expansions, and mergers. To see what's happened in the industry in the past two weeks, see below.

With this article, we will begin posting a semi-monthly online wrap-up of Industrial Leadership, Expansions, and Mergers and Acquisitions short news items of interest to our readers. If you have news items that should be included in this category, please feel free to send them to the editor, Beth G....

The Association of Southeast Asian Nations (ASEAN), a regional economic organization consisting of Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam is developing a combined regulatory system for medical devices to cover all member countries. The ASEAN Medical...

Singapore's Health Sciences Authority (HSA), the country’s medical device market regulator, has implemented new rules in order to expedite market access for lower-risk medical devices. The rules will exempt all Class A medical devices (except sterile Class A products) from HSA registration...

The National Space Biomedical Research Institute (NSBRI) is soliciting ground-based, analog definition and flight definition proposals. NSBRI is soliciting proposals for six of its seven research teams. Topic areas include smart medical systems and technology to refine and validate plug-and-play sensor and...

A revision of the Waste Electrical and Electronic Equipment (WEEE2) Directive was published in the Official Journal of the European Union on July 24. While it is mainly for European waste and recycling industries, some aspects will have consequences for the medical device industry since,...

IEEE has announced four IEEE 11073™ standards-development projects intended to expand support for plug-and-play, interoperable medical-device communications. These standards will help support patients living with chronic diseases like asthma, diabetes, congestive...

Nanotechnology, the science of manipulating matter on a molecular scale, offers obvious advantages for the medical market. However, the question of nanotoxicology — the study of the toxicity of nanomaterials — may also play a role in the future of this technology. In 2006, the FDA formed the...

Texas...home of Johnson Space Center, the NSBRI, good BBQ, and now, for the first time, the Medical Design & Manufacturing (MD&M) show. Last week, in Fort Worth, TX, local exhibitors demonstrated evidence of the Lone Star State as an important hotspot for medical device development.

If a prosthesis is not fit or aligned correctly, it can affect a patient's walking patterns, resulting in an asymmetric gait. These abnormal gait patterns can increase the stress on the healthy limb, leading to problems later in life such as arthritis. Researchers at Oak Ridge National...

At an estimated $105.8 billion, the U.S. medical device market may be the world's largest, but it could do with a healthy boost of innovation.* According to a recent White House blog post, "In trying to understand why the country’s pharmaceutical, biotech and medical device sectors seem to be...