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Industry News: Medical
October Month-End News from Industry

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

News: Medical
First Annual International Day of Radiology Celebrated

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...

News: Medical
FDA Seeks Comments on Draft Guidance for eCopy for Device Submissions

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "eCopy Program for Medical Device Submissions,'' for industry and FDA staff. The purpose of the draft guidance is to explain the new electronic copy (eCopy) program for medical...

Industry News: Medical
October Mid-Month Industry News

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...

News: Green Design & Manufacturing
First Medical Device Reprocessing Training Program

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...

News: Medical
SMARTCAP Award Seeks Medical Technology for Space Use

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 News: Medical
September Industry News Wrap-Up

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.

News: Medical
FDA Compiles FAQ List for Device Listing Changes

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...

News: Medical
Reshoring Initiative Celebrates First Anniversary

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...

Industry News: Medical
September Mid-Month Industry News

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.

Industry News: Medical
August 2012 Medical Design Briefs News Wrap-up

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...

News: Medical
Asia Developing Device Regulations

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...

News: Regulations/Standards
Singapore Eases Market Entry for Lower-Risk Devices

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...

News: Medical
NSBRI Soliciting Research Proposals

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...

News: Medical
European Directive to Impact the Medical Devices Industry

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,...

News: Medical
Seeking Participants to Help Develop Standards for Medical Device Communications

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...

News: Medical
Nanotechnology's Big Medical Implications

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...

News: Manufacturing & Prototyping
A (Texas) Toast to Biomedical Innovation

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.

News: Medical
Portable, Wearable System Improves Prosthesis Fitting, Design

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...

News: Medical

Last week, at Medical Design & Manufacturing (MD&M) Minneapolis, we had the chance to catch up with some companies and, in some instances, view their latest products in action on the trade show floor.

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News: Medical
Can the FDA Successfully Spark Innovation in the U.S.?

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...

Ask the Expert

Ralph Bright on the Power of Power Cords
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Understanding power system components and how to connect them correctly is critical to meeting regulatory requirements and designing successful electrical products for worldwide markets. Interpower’s Ralph Bright defines these requirements and explains how to know which cord to select for your application.

Inside Story

Inside Story: Establishing Safe EO Sterilization for Medical Devices
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To find out more about the expertise required to establish a safe and effective EO Sterilization for medical devices, MDB recently spoke with Elizabeth Sydnor, director of microbiology for Eurofins Medical Device Testing (Lancaster, PA).

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