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Policy & Regulation
Immediate improvements sought in EU-wide surveillance of medical devices post-PIP
03 February 2012
The European Commission is looking at "immediate measures" to improve the surveillance of medical devices within the existing legal framework in light of the sub-standard PIP breast implants affair. The commission will launch a discussion with all ...
 
PIP breast implants sold in 71 countries, not 66, according to French report
02 February 2012
The French government has published a comprehensive report on the history, current situation and implications of the crisis involving fraudulent silicone breast implants made by the now-defunct Poly Implant Protheses (PIP). Among the most ...
Kenya issues guidance on marketing devices and devices
01 February 2012
The Kenyan Pharmacy and Poisons Board has issued guidance explaining the current minimum requirements for advertising and promoting drugs and medical devices in the country. The guideline stipulates, among other things, the procedures that ...
 
Aerocrine gets expanded US reimbursement coverage; clears more Asian reg hurdles
13 January 2012
Inflammatory airway disease specialist Aerocrine has gained expanded reimbursement coverage in the US for its Niox Mino device for managing asthma, and won marketing clearance for two new Asian markets. The Solna, Sweden-based firm's device measures ...
NHS seeking efficiency and quality in dentistry reforms 11 April 2011

The UK government is planning to reform the reimbursement of NHS dentistry in England, by reimbursing according to quality of care rather than the number of treatments provided. New contracts are to be drawn up, “based around capitation, ...

 
Kenya issues guidance on marketing devices and devices
01 February 2012
The Kenyan Pharmacy and Poisons Board has issued guidance explaining the current minimum requirements for advertising and promoting drugs and medical devices in the country. The guideline stipulates, among other things, the procedures that ...
Brazil enacts key healthcare investment legislation
01 February 2012
Brazil has enacted Emenda Constitucional 29 (EC29), a fundamental piece of health services programming and investment legislation. The sanctioning of the “complementary law” Lei Complementar No.141 by President Dilma Rousseff brings into effect a ...
 
NICE confirms rejection of Gen-Probe and Progenika hypercholesterolaemia tests
14 December 2011
Molecular diagnostics companies Gen-Probe and Progenika were dealt a blow by the UK’s National Institute for Health and Clinical Excellence (NICE) when the latter published final guidance recommending against routine use of Gen-Probe’s Elucigene ...
Epiretinal brachytherapy for wet AMD gets NICE thumbs down
14 December 2011
Epiretinal brachytherapy for treating wet age-related macular degeneration (AMD) should only be used in the context of research, the UK’s National Institute for Health and Clinical Excellence (NICE) has said. In guidance issued today under its ...
 
US FDA invites comments on introducing UDIs in electronic data healthcare systems
26 July 2011
The US Food and Drug Administration is to hold a workshop in which it will seek stakeholder feedback on the adoption, implementation and use of unique device identifiers in various health-related electronic data systems. Implementing UDIs in ...
China issues interim provisions on device recalls
22 June 2011
China's State Food and Drug Administration has promulgated interim provisions relating to its management of the medical device recall process. The new provisions, comprising six chapters and 38 articles, are due to come into effect on 1 July. The ...
 
The growing role of diagnostics-based models in combating antimicrobial resistance
30 January 2012
Ashley Yeo

Recent scientific and regulatory advances have pointed to the growing role of molecular diagnostics and personalised medicine in many areas including control of antimicrobial resistance. Ashley Yeo speaks to medical device industry consultant Trevor ...

 
Refurbishment and reprocessing - threat or opportunity for medical device manufacturers?
31 January 2012
Medical device refurbishment – restoring devices to their original specifications – has gained in importance as healthcare budgets have come under pressure. While some countries actively ban imports of such devices, attitudes generally towards the ...
 Growing EU demand for second-hand devices: regulatory void t...   French medtech entrepreneurialism needs infrastructural back...
The growing role of diagnostics-based models in combating antimicrobial resistance
30 January 2012
Recent scientific and regulatory advances have pointed to the growing role of molecular diagnostics and personalised medicine in many areas including control of antimicrobial resistance. Ashley Yeo speaks to medical device industry consultant Trevor ...
How the IMDRF needs to act to succeed better than GHTF in regulatory harmonisation
24 January 2012
The medical device industry expects much more from the International Medical Device Regulators' Forum (IMDRF) than its predecessor, the GHTF, in many areas of its work of global medical device regulatory harmonisation. So concludes a recent report, ...
Advanced Therapies: is the EU regulatory approach putting a brake on market development?
19 January 2012
Amanda Maxwell

There is no doubt that the European Medicines Agency's Committee for Advanced Therapies (CAT) has put considerable effort into developing a significant number of guidelines to explain how it operates in the complex field of advanced therapy ...

 

Softening CRM sector in need of more pace and rhythm
03 February 2012
Ashley Yeo

Cardiac rhythm management remains a $2bn business at Boston Scientific , but a 15% slide (in both reported and constant currencies) in sales in the final quarter of 2011, reported yesterday, meant that the group’s second-largest business unit ...

 
Clinica 100
28 October 2011

This year's Clinica 100: Analysis of the Medtech Industry is now out with the December issue. This special 24-page section features: - Clinica League Tables - Top 100 medtech companies and Top 20 Sector Leaders - Interviews offering insight into ...

 
EVENTS
The 14th MedTech Investing Europe conference
19 March 2012
Montreux Convention and Music Centre, Switzerland
HTAi 2012
23 June 2012
Bilbao, Spain
 
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