Elekta taps Brainlab as select EU distro partner for stereotactic neuro devices
Elekta (STO:EKTA B) said today it tapped Brainlab to distribute its stereotactic neurological devices across select markets in the European Union. The distribution agreement covers Elekta’s Leksell Vantage Steretactic target localization and coordinate referencing neurosurgery system, the company said, which received CE Mark approval in the EU in March. The device is currently pending 510(k) clearance in the US, Elekta added. The agreement also covers the Leksell Stereotactic system and Elekta Microdrive. “Elekta is a leader of equipment for stereotactic neurosurgery and Brainlab has a strong presence in t...
Source: Mass Device - June 29, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Neurological Surgical Brainlab Elekta AB Source Type: news
Fluid glass in windows which could provide an energy
In Liechtenstein a project is developing windows which could provide a source of energy. The outer face of the window is able to collect solar radiation and transform it into energy and the inner face is able to cool or heat the space inside the container. (Source: EUROPA - Research Information Centre)
Source: EUROPA - Research Information Centre - May 17, 2017 Category: Research Source Type: news
Seattle Genetics drug gets OK for additional cancer therapies in Europe
Seattle Genetics’s treatment for high-risk Hodgkin lymphoma patients can now be marketed in Europe. Seattle Genetics (Nasdaq: SGEN) says its global distribution partner Takeda Pharmaceutical Co. has received permission from the European Commission to market Adcetris in 28 EU member countries and Norway, Liechtenstein and Iceland. Adcetris is already commercially available in more than 60 countries around the world, including throughout the EU for two other uses — relapsed Hodgkin lymphoma and… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - July 6, 2016 Category: Pharmaceuticals Authors: Becky Monk Source Type: news
What will Brexit mean for medical device companies?
By Ronald Boumans, Emergo Group In a stunning referendum on June 23, UK voters decided to leave the European Union (EU). This historic vote has many medical device companies – inside and outside the UK – wondering what the future holds for the regulation of devices and IVDs sold in the country. The UK’s top medical device regulator – the MHRA – issued this statement, in which they say that they expect to keep doing their work as usual. Under the current regulatory framework, companies selling medical devices in the UK must abide by Europe’s medical device, IVD or active implan...
Source: Mass Device - June 27, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Emergo Group Source Type: news
Here's Why 'Brexit' Could Be A British Public Health Disaster
Britons voted on the "Brexit" referendum on Thursday to decide whether to exit the European Union. Ballots aren't yet tallied, but the result is likely to hinge on voter opinion about immigration. Officially, the referendum is about the pros and cons of remaining in the EU, an economic partnership between the 28 member countries that allows people, goods and information to move easily through the region. A possible exit from this partnership would have an impact on issues as wide-ranging as the economy, scientific research, the labor force, British vacation time and the future of the British territory o...
Source: Healthy Living - The Huffington Post - June 23, 2016 Category: Consumer Health News Source Type: news
Climate Deception: Non-binding "Targets" for Climate, but Binding Rules on Trade in Services
The whole world is watching as world leaders from nearly every country across the globe meet in Paris this week to set carbon emission reductions targets to address global climate change. Unfortunately representatives of 50 of the same governments are also meeting this week in Geneva to negotiate binding rules that will seriously constrain countries' ability to meet those targets. The 15th round of talks to create a "Trade in Services Agreement," or TiSA, are occurring once again in Geneva. Members of the TiSA currently include Australia, Canada, Chile, Colombia, Costa Rica, Hong Kong, Iceland, Israel, Japan, L...
Source: Science - The Huffington Post - December 4, 2015 Category: Science Source Type: news
Elocta Approved in Europe for Hemophilia AElocta Approved in Europe for Hemophilia A
The European Commission has approved Elocta for the treatment of hemophilia A in all 28 European Union member states, Iceland, Liechtenstein, and Norway. International Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - November 25, 2015 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news
Gilead's Hepatitis C Treatment Sofosbuvir Gets European Commission Nod
Gilead Sciences’ Sofosbuvir, a hepatitis C treatment potentially faster and more effective than current therapies, has been approved by the European Commission. The European Commission approval predicates marketing rights for Gilead in all European Union countries including European Economic Area countries Iceland, Norway, and Liechtenstein. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - January 21, 2014 Category: Pharmaceuticals Source Type: news
Bavarian Nordic receives European marketing authorization for Imvanex smallpox vaccine
Bavarian Nordic A/S (OMX: BAVA) announced today that the European Commission has granted marketing authorization for IMVANEX® (MVA-BN) for active immunization against smallpox disease for the general adult population, including people with weakened immune systems (people diagnosed with HIV or atopic dermatitis). The authorization covers all 27 European Union member states and European Economic Area countries Iceland, Liechtenstein and Norway. IMVANEX will be made available for governments to purchase and use in accordance with official national recommendations... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - August 9, 2013 Category: Consumer Health News Tags: Regulatory Affairs / Drug Approvals Source Type: news