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clinica
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 ...
First detailed EU guidance on authorised representative's role now available
03 February 2012
The European Commission has published a new EU Guideline for Authorised Representatives on its website. The guideline, MEDDEV 2.5/10 of January 2012 , represents the first single, collated document to shed light on the role of the authorised ...
S&N's cost-cutting efforts hike up Q4 trading margin
02 February 2012
Smith & Nephew beat its trading profit margin target in the fourth quarter of 2011, thanks largely to the company's efforts to curb costs and create a more streamlined organisation. The firm reported trading profit of $279m in Q4, on the back of a ...
Industry gives nod to doubling of US FDA user fees - in exchange for improved approval process
02 February 2012
US medtech industry association AdvaMed has reached a tentative user fee agreement with the FDA in which companies would pay the agency twice as much to have their products evaluated, in exchange for a faster and more predictable review process. The ...
 
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 ...
Canon enters medical informatics with Delft acquisition
03 February 2012
Canon Europe, part of the Japanese imaging and camera specialist Canon , has bought Dutch firm Delft Diagnostic Imaging, expanding its X-ray capabilities and giving it a foothold in the medical informatics market. Financial terms of the deal were ...
First detailed EU guidance on authorised representative's role now available
03 February 2012
The European Commission has published a new EU Guideline for Authorised Representatives on its website. The guideline, MEDDEV 2.5/10 of January 2012 , represents the first single, collated document to shed light on the role of the authorised ...
Quarterly results round-up: Getinge and Philips look to restructuring to save costs
02 February 2012
Swedish medtech firm Getinge beat analysts' estimates in its fourth fiscal quarter due to "strong margin improvements", according to Jefferies analyst Ingeborg Øie. Q4 net sales were up 11% to SEK7.35bn ($1.09bn), while net income also increased to ...
 
French allergy company DBV takes first step towards 2012 IPO
03 February 2012
Allergy treatment specialist DBV Technologies is planning an initial public offering on the NYSE Euronext exchange this year. The company has taken the first step of filing its “Document de Base” with the French Autorité des marchés financiers ...
Canon enters medical informatics with Delft acquisition
03 February 2012
Canon Europe, part of the Japanese imaging and camera specialist Canon , has bought Dutch firm Delft Diagnostic Imaging, expanding its X-ray capabilities and giving it a foothold in the medical informatics market. Financial terms of the deal were ...
Quarterly results round-up: Getinge and Philips look to restructuring to save costs
02 February 2012
Swedish medtech firm Getinge beat analysts' estimates in its fourth fiscal quarter due to "strong margin improvements", according to Jefferies analyst Ingeborg Øie. Q4 net sales were up 11% to SEK7.35bn ($1.09bn), while net income also increased to ...
S&N's cost-cutting efforts hike up Q4 trading margin
02 February 2012
Smith & Nephew beat its trading profit margin target in the fourth quarter of 2011, thanks largely to the company's efforts to curb costs and create a more streamlined organisation. The firm reported trading profit of $279m in Q4, on the back of a ...
 
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 ...
First detailed EU guidance on authorised representative's role now available
03 February 2012
The European Commission has published a new EU Guideline for Authorised Representatives on its website. The guideline, MEDDEV 2.5/10 of January 2012 , represents the first single, collated document to shed light on the role of the authorised ...
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 ...
Industry gives nod to doubling of US FDA user fees - in exchange for improved approval process
02 February 2012
US medtech industry association AdvaMed has reached a tentative user fee agreement with the FDA in which companies would pay the agency twice as much to have their products evaluated, in exchange for a faster and more predictable review process. The ...
 
PEOPLE
Zabrowski to head Roche Applied Science Roche has appointed Dan Zabrowski head of its Applied Science business. The position has been vacant since September last year, after the departure ...
Covidien CEO completes takeover from Meelia with chairman role Covidien president and CEO José Almeida is to assume the additional role of chairman, effective 13 March 2012. Mr Almeida succeeds Richard Meelia, ...
Siemens veteran becomes Toshiba president Toshiba America Medical Systems (Tustin, California) has appointed Donald Fowler president as it seeks to grow its market share in the US. Mr Fowler ...
>> More People News...
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 ...

 
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 ...

Refurbishment and reprocessing - threat or opportunity for medical device manufacturers?
31 January 2012
Ashley Yeo

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 ...

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 ...

 
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 ...

 
VIDEOS/PODCASTS
Webinar replay: Successful US medtech strategies
14 April 2011
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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 ...

 
The clinical diagnostics market – strategies for success
05 December 2011
Intelab Corp

The clinical diagnostics industry is evolving with the entry of a major new company from the medical device sector, emergence of a major new competitor in point-of-care (POC) diagnostics, an increasingly global level of competition, and differing ...

 
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 ...

 
Organovo's bioprinter for new tissue and EStimME expands into middle ear drug delivery
24 November 2011
Phil Greenfield

Clinica’s Patent Watch focuses on key growth areas of regenerative medicine, or where there is potential to selectively treat disease with drugs in personalised treatments, as is the case with emerging areas of drug delivery and molecular ...

 
 
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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