E.U. regulators dishing out fewer CE Marks, study finds | MassDevice.com On Call

MassDevice On Call

MASSDEVICE ON CALL — European regulators have become increasingly coy with their CE Markings, especially for new medical devices, according to a report by the European Assn. for Medical Devices of Notified Bodies, or TEAM-NB.

A survey comparing data from 2010 to 2012 showed a decrease in CE Mark certificates overall and a "significant" decrease in new CE Marks, TEAM-NB reported. The trends are consistent among Europe-based as well as non-European companies, they added.

 Low risk prostate cancer is increasingly over-treated, study says
A recent study reported that advanced treatments for prostate cancer are on the rise, even in patients that are not likely to benefit from a more aggressive procedure.

The authors pegged this trend to direct-to-consumer advertisements and fee-for-service medical payments. The uptick in advanced radiation and surgical treatments has many concerned about over-treatment of a manageable, low-risk disease.
Read more

 Mass. Senate wants exemption from certain parts of Obamacare
Governor Deval Patrick might have to ask Obama to duck out of part of healthcare reform based on a new waiver filed by the Mass. Senate. Democratic budget writer for the Commonwealth, Senator Stephen Brewer, is pushing back hard against policies he and others fear will increase insurance premiums, some by as much as 50%, for a majority of the Bay State’s small businesses.
Read more

 New laws would allow PAs, nurses to order home healthcare for Medicare
Four large nursing and home healthcare associations put their weight behind a proposal to give physician assistants and nurses more clinical decision-making power.

A bipartisan proposal in the House would allow PAs and nurses to order home healthcare for elderly Medicare patients, a measure that would be especially important in rural areas where patients have little access to primary care.
Read more

 Senate proposes "rewards" program for seniors with good health
U.S. Senators Ron Wyden (D-Ore.) and Rob Portman (R-Ohio) want to reward Medicare recipients who stay healthy, using savings expected to be generated by healthier seniors to fund the program.

The duo proposed a measure that would offer healthy seniors hundreds of dollars for meeting goals in general wellness criteria such as blood pressure, cholesterol and tobacco use, with rewards growing to $400 by the program’s 3rd year.
Read more

RSS From Medical Design & Outsourcing

  • MTD Micro Molding releases micro materials menu
    MTD Micro Molding, a long-time leader in micro-injection molding, has released an updated “Materials Menu” of materials that can be successfully micromolded to help guide engineers at medical device companies. Material selection is a crucial step in product manufacturability. The correct material drives tolerance, dimension, strength, usabality, speed-to-market, design, critical features, and cost. Through MTD’s […]
  • MedTech Chat: Elastic technology for drug delivery
    Dr. Zhen Gu and Dr. Yong Zhu from North Carolina State University are both co-senior authors of a research paper describing their recent work. Dr. Gu, Dr. Zhu and other researchers from North Carolina State University and the University of North Carolina at Chapel Hill have developed a drug delivery technology that consists of an […]
  • B. Braun’s OEM Division offers large bore normally closed low-pressure check valves
    Infusion therapy and pain management device manufacturer B. Braun said today it is offering normally closed large-bore low-pressure check valves through its valve-focused contract manufacturing OEM division. The valves, offered by Bethlehem, Pa.-based B. Braun, are designed for the intermittent injection of fluids during medical treatment and open automatically when pressure is applied. The newly […]
  • Continuous 225W with natural convection for medical type BF power supply
    Powerbox, a European power supply company, introduces new Medline 225 series ac and dc single output open frame converters for medical type BF applications. The new OFM225 with its 3 x 5 in. footprint and 1.5 in. height is designed for a continuous output power of 225W with natural convection and 40°C ambient temperature, increasing to […]
  • Using data science to achieve ultra-low dose CT image reconstruction
    Prof. Jeff Fessler and Prof. Yong Long, Ph.D. of the University of Michigan-Shanghai Jiao Tong University (UM-SJTU) Joint Institute are collaborating on a project to develop a dramatically improved approach to low-dose X-ray CT image formation by extracting and using information from a big-data corpus of regular dose X-Ray Computed Tomography (CT) images. The research is […]
  • New vented dust caps from Qosina prevent damage and contamination on a new level
    Qosina is pleased to announce the addition of eleven new soft TPE vented dust caps (#11300, #11301, #11320, #11330, #11331, #11340, #11341, #11350, #11360, #11361 and #11380) in stock and ready for immediate delivery. These components are available in a variety of colors including blue, green, red, white and yellow; sizes range from 0.187 in. […]
  • Nader Najafi: A dream that saves lives
    Miniature wireless sensing and computing devices have the potential to improve people’s health, even save lives. Twenty years ago, working on microelectromechanical systems (MEMS) as a student at Michigan, Dr. Nader Najafi had a dream to be part of this future reality. He turned that dream to action when he left a promising career at […]
  • PBC Linear’s guide for approved bearing inspection method
    Understanding the method to properly inspect the Frelon liner in PBC Linear’s Simplicity plain bearings is essential to taking full advantage of the product. The Frelon liner supplies numerous attributes that make it preferable in many unique applications; however, being a teflon-based material requires a different method of inspection: Approved Inspection Method: Pin Gauges (AKA: Go or […]
  • 3W to 10W DIP-24 DC-DC converters have medical certification
    TDK announces the introduction of the TDK-Lambda PXC-M series of DC-DC converters. Operating over a 4:1 input range, the 3W, 6W and 10W products are enclosed in the industry standard 1.25 x 0.8 x 0.4 in. DIP-24 package. Applications include a wide variety of medical applications and battery powered equipment. With a 5,000 Vac input […]
  • How do you mend a broken heart? By converting fat cells into stem cells that can help that vital organ repair itself
    Editor’s Note: This article is written by Jeannie Kever and discusses the recent research from the University of Houston. There has been little time to savor the successes of the moment as Dr. Robert Schwartz and members of his lab push relentlessly toward their goal. Their goal is to begin clinical trials that will showcase how common fat cells, treated […]
  • MNX Global Logistics opens new Life Sciences Logistics Center in Amsterdam
    MNX Global Logistics announces the opening of its dedicated supply chain and logistics facility in Amsterdam, the Netherlands, located just outside of Amsterdam Airport Schiphol. This facility with validated temperature-controlled supply chain capabilities will serve as the operations and warehousing hub for its life sciences and medical device customers throughout Europe. “The demand for our services […]

Leave a Reply