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28 May 2015

 
28 May 2015
Companies seeking to register Class II and III medical devices for sale in China now have to start paying fees amounting to tens of thousands of US dollars to the China Food and Drug Administration. Neither domestic nor foreign medical device ...
28 May 2015
When it comes to how the reprocessing of single-use devices will be regulated under new EU rules, the Council of the European Union – made up of member state representatives - looks likely to come to its own agreement rather than adopt the proposals ...
27 May 2015
The German government is currently in the final stages of deliberating a new draft law aimed at eradicating bribery in the healthcare sector, a law that – once enacted - will create particular challenges for medical device companies. The Federal ...
26 May 2015
The latest development in a long drawn-out patent infringement wrangle between Philips and Masimo may have been in the latter’s favor but the fight is far from over, according to Philips. A US court last week upheld a 14 October 2014 ruling which ...
 
28 May 2015
Biocartis is partnering with Fast-track diagnostics to develop syndromic multiplex tests that will run on Biocartis’ Idylla analyzer and the first assay is expected to be ready two years from now. The assay will be a multiplex respiratory panel for ...
26 May 2015
St Jude Medical had a heavy focus on its intravascular imaging offering at this year’s EuroPCR meeting, presenting data supporting its optical coherence tomography (OCT) technology. OCT provides intravascular images to help assess culprit lesions, ...
26 May 2015
The latest development in a long drawn-out patent infringement wrangle between Philips and Masimo may have been in the latter’s favor but the fight is far from over, according to Philips. A US court last week upheld a 14 October 2014 ruling which ...
22 May 2015
A big topic at this year’s EuroPCR, held in Paris on 19-22 May, was drug-coated balloons (DCBs). One of the leaders in the field, Medtronic, presented positive data from two studies of its IN.PACT Admiral balloon, which could support an expanded ...
 
28 May 2015
Biocartis is partnering with Fast-track diagnostics to develop syndromic multiplex tests that will run on Biocartis’ Idylla analyzer and the first assay is expected to be ready two years from now. The assay will be a multiplex respiratory panel for ...
27 May 2015
The German government is currently in the final stages of deliberating a new draft law aimed at eradicating bribery in the healthcare sector, a law that – once enacted - will create particular challenges for medical device companies. The Federal ...
26 May 2015
The latest development in a long drawn-out patent infringement wrangle between Philips and Masimo may have been in the latter’s favor but the fight is far from over, according to Philips. A US court last week upheld a 14 October 2014 ruling which ...
15 May 2015
Around 71% of Africa’s health burden comes from communicable diseases but non-communicable diseases such as cancer are increasing rapidly. This shift brings growth opportunities for companies such as radiotherapy specialist Varian Medical Systems. ...
 
28 May 2015
Companies seeking to register Class II and III medical devices for sale in China now have to start paying fees amounting to tens of thousands of US dollars to the China Food and Drug Administration. Neither domestic nor foreign medical device ...
28 May 2015
When it comes to how the reprocessing of single-use devices will be regulated under new EU rules, the Council of the European Union – made up of member state representatives - looks likely to come to its own agreement rather than adopt the proposals ...
27 May 2015
The German government is currently in the final stages of deliberating a new draft law aimed at eradicating bribery in the healthcare sector, a law that – once enacted - will create particular challenges for medical device companies. The Federal ...
26 May 2015
Several EU harmonized standards in the areas of cardiology and haemodialysis are expected to be out later than planned, with some not available until next year. Work on EU standards often takes longer than expected, which can lead to delays in ...
 
Sorin, Cyberonics reveal post-merger exec team With the merger of heart device company Sorin and neurostimulation specialist Cyberonics on track to close at the end of the third quarter, the ...
New CEO brings commercial nous to NetScientific NetScientific, the UK group which invests in biomedical and healthcare companies, has appointed François Martelet as CEO and board director. Dr ...
Siemens exec to lead Curetis commercialization Molecular diagnostics firm Curetis has appointed Achim Plum to the newly-created role of chief commercial officer. Dr Plum’s in vitro diagnostics ...
27 May 2015
Amanda Maxwell

For the last two and a half decades, the careers of EU medtech regulatory experts have orbited around the output of Brussels and its impact at EU, national and even international level. So should those of us in the UK fear the referendum on EU ...

20 May 2015
Ashley Yeo

How the promised EU in/out referendum for the UK, in 2016 or 2017, will affect industry is now the big concern for UK medtech companies, as the dust settles on the UK general election. There is no certainty as to the outcome, and the slim 12-seat ...

 
27 May 2015
Amanda Maxwell

For the last two and a half decades, the careers of EU medtech regulatory experts have orbited around the output of Brussels and its impact at EU, national and even international level. So should those of us in the UK fear the referendum on EU ...

20 May 2015
Ashley Yeo

How the promised EU in/out referendum for the UK, in 2016 or 2017, will affect industry is now the big concern for UK medtech companies, as the dust settles on the UK general election. There is no certainty as to the outcome, and the slim 12-seat ...

13 May 2015
Ashley Yeo

While the attention of the EU industry has been fixed on how the EU Council will play the controversial elements of the proposed EU Medical Device Regulation (MDR) – the Article 44 scrutiny clause above all else – tougher market access rules for ...

 
30 April 2015
Madeleine Armstrong

Sphere Medical has been on Clinica’s radar for some time, but the UK firm has lately been ramping up its activities, appointing a new CEO and getting CE mark approval for its Proxima 3 blood analyzer last year. The company has just closed a share ...

 
“Beyond Compliance”: a self regulation tool to add strength to the CE marking – podcast
16 December 2013
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22 October 2014
Amanda Maxwell

The future regulation of high-risk devices is one of the trickiest subjects in the proposed EU Medical Device Regulation (MDR) on which to reach final agreement, with the different parties involved seemingly at loggerheads. Delegates at the European ...

 
31 May 2012
Hua Gong

Cancer diagnostics provide a promising future for unraveling the mystery of one of the leading killer diseases and helping to better detect and treat it. However, companies are currently facing a number of potential challenges when developing cancer ...

 
20 April 2015

Specialty area(s): Devices for bowel control Based in: Sunnyvale, California Founded in: 2010 No. of employees: 18 Total investment received to date: Undisclosed Investors: Led by Norwich Ventures

 
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 ...

 
 
 
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