MEDTEC France - 2012, une première à Lyon !

Is CE Mark ?Good Enough?? LinkedIn Members Weigh In

Over the years, a growing number of medical device companies in the United States have decided to obtain the CE mark for new products before attempting to approve products through FDA. While FDA is not monolithic, many in the industry view the European system as generally more consistent, transparent, and often easier to deal with [...]

Why Is the United States Upset Over the Device Levy?

Nick Woods, Director of Hill Woods Medical Media Ltd, has written an editorial for MD+DI. In it, Woods explains that US manufacturers aren?t really arguing the right way to get the device tax repealed. ?The only problem is, chaps, that the legislature is either not listening or it doesn?t believe you. Lobby all you like, but [...]

Medisiams and World Medtech Forum Lucerne Join Forces

Medisiams, the supplier trade fair from West Switzerland, is going to be integrated into the World Medtech Forum Lucerne held from 25 to 27 September 2012 in Lucerne, Switzerland. This decision was made by the Medical Cluster, Medtech Switzerland, Siams SA and Messe Luzern AG to establish Switzerland as a vital hub for the research, development and production [...]

Nano Tech Japan Highlights Life Science Applications

After celebrating its 10th anniversary last year, nano tech 2012 – The 11th International Nanotechnology Exhibition & Conference will take place 15 to 17 February 2012 at the International Exhibition Center Tokyo Big Sight in Japan. After highlighting “green nanotechnologies” in previous years, life science applications of nanotechnology will be added as a new focus of the exhibition. Under [...]

Russia to Release New Medical Device Regulations

Russia is expected to release new medical device regulations within the next few weeks, writes Stewart Eisenhart, an editor covering regulatory affairs for Emergo Group, in a blog post on the Massdevice website. Eisenhart expects the regulations to be clearer and have more specific requirements than current regulations, for example by providing reporting timelines and [...]

Nano Loudspeaker Could Improve MRI Technology

If a theory about detecting extremely faint electrical signals by means of a nanomechanical loudspeaker can be shown to work in experiments, it could result in much simpler MRI procedures, reports Nanowerk News. A team of physicists from the Joint Quantum Institute and Harvard University in the United States and the Neils Bohr Institute in Denmark [...]

Medilink Launches Medtech Funding Resource

UK medtech business support organisation Medilink has launched a funding and finance leads service for companies operating in the life sciences sector. The service provides subscribing companies with access to a regularly updated database compiling sources that are willing to fund innovation. “Many firms in the [UK health technology] sector are SMEs, which are finding it [...]

MEDDEV Guidelines on Stand-Alone Medical Software Published

The MEDDEV guidelines on stand-alone software have just been published, prompting the question: What does it all mean? We asked lawyer and blogger Erik Vollebregt. He had the answers (and a few more questions). Vollebregt is a partner at Amsterdam-based life sciences boutique law firm Axon Lawyers and maintains the medicaldeviceslegal blog. medtechinsider: Can you give us [...]

UK Spin-Out Company Markets Biomedical Carbon with Unique Properties

Mast Carbon, a manufacturer of synthetic carbon?based specialty materials based in Basingstoke, UK, has established a spin-out company to commercialise biomedical carbon in a joint venture with Second Mile. Named Acesco Health, the spin-out is developing a proprietary range of activated carbon bead products that combine the usual benefits of activated carbon with some specific [...]

Japan?s Regulatory Agency Goes Back to School

Japan?s Pharmaceuticals and Medical Devices Agency (PMDA) has entered into a collaboration with Gifu University to promote education and research involving medical technology. Under the agreement, students at Gifu University?s United Graduate School of Drug Discovery and Medical Information Sciences can attend classes taught by PMDA staff and have an opportunity to spend time working [...]