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23 September 2014

 
22 September 2014
The UK Medicines and Healthcare Products Regulatory Agency is inviting feedback from medical device manufacturers on its plans to introduce a fee for processing each certificate of free sale (CFS) application as of April 2015. CFSs are currently ...
19 September 2014
The talk of this year’s ESC conference was the failure of Boston Scientific’s NECTAR-HF study to show the benefit of vagal nerve stimulation (VNS) in heart failure. But the company is refusing to condemn VNS to the scrapheap just yet – although it ...
18 September 2014
Boston Scientific’s Watchman left-atrial appendage closure device missed its primary efficacy endpoints, according to the latest follow-up report from the PREVAIL trial. The data, presented at this week’s Transcatheter Cardiovascular Therapeutics ...
18 September 2014
A proposal by the US FDA to amend and clarify its regulations governing classification and re-classification of medical devices could fundamentally change the classification process and result in more devices having to undergo the more stringent ...
 
22 September 2014
The UK Medicines and Healthcare Products Regulatory Agency is inviting feedback from medical device manufacturers on its plans to introduce a fee for processing each certificate of free sale (CFS) application as of April 2015. CFSs are currently ...
19 September 2014
Nexstim, the Finnish specialist in navigational transcranial magnetic stimulation, has joined this year’s growing wave of medtech IPOs by seeking to raise €20m on the Nasdaq OMX First North market. It expects to be admitted into the stock exchange ...
19 September 2014
The talk of this year’s ESC conference was the failure of Boston Scientific’s NECTAR-HF study to show the benefit of vagal nerve stimulation (VNS) in heart failure. But the company is refusing to condemn VNS to the scrapheap just yet – although it ...
18 September 2014
Medtronic is casting off its MicroFrance and Xomed manual ENT and laparascopy instrumentation lines to Integra LifeSciences for $60m cash. Integra will fund the transaction with cash from outside the US. From this acquisition, Integra will gain a ...
 
19 September 2014
Nexstim, the Finnish specialist in navigational transcranial magnetic stimulation, has joined this year’s growing wave of medtech IPOs by seeking to raise €20m on the Nasdaq OMX First North market. It expects to be admitted into the stock exchange ...
16 September 2014
A group led by ex-Alere CEO Ron Zwanziger has made a move to buy the beleaguered company, for an estimated price of $3.82bn. Mr Zwanziger, who resigned unexpectedly from Alere in July , made a Schedule 13D filing with the US Securities and Exchange ...
15 September 2014
ReWalk Robotics has priced its initial public offering and started trading on the Nasdaq – but the total $36m raised fell short of its previous target. The firm initially said it wanted to pull in $57.5m; then reduced this target to around $51m. ...
15 September 2014
UK diagnostic specialist Immunodiagnostic Systems (IDS) has reduced its guidance, leading to at least one analyst reclassifying its stock as “sell.” The company is now expecting sales for the fiscal year ending March 2015 of £45-47m ($73-76m), ...
 
22 September 2014
The UK Medicines and Healthcare Products Regulatory Agency is inviting feedback from medical device manufacturers on its plans to introduce a fee for processing each certificate of free sale (CFS) application as of April 2015. CFSs are currently ...
18 September 2014
A proposal by the US FDA to amend and clarify its regulations governing classification and re-classification of medical devices could fundamentally change the classification process and result in more devices having to undergo the more stringent ...
17 September 2014
September marked the inaugural session of Clinica’s new monthly Access All Asia forum, which provides a platform for a core group of Asia-focused regulatory professionals to crosscheck intelligence regarding developments in the region, discuss ...
17 September 2014
A common market in medical device registration for the member countries of the new Eurasian Economic Union (EEU) is being discussed in a consultation posted by the Russian Federation on 3 September. Issued under the auspices of the World Trade ...
 
Insulet bags veteran Patrick Sullivan as new CEO Insulin pump specialist Insulet has appointed Patrick Sullivan CEO, with long-time leader Duane DeSisto retiring after 13 years with the firm. ...
Ex-Acrobot CEO to head up Reapplix Privately-held Danish wound care specialist Reapplix has appointed Graeme Brookes CEO. Mr Brookes previously led robotic technology specialist ...
Hellebø replaces Hunt at the helm of stem cell firm ReNeuron UK stem cell specialist ReNeuron has appointed pharma veteran Olav Hellebø CEO with immediate effect. Mr Hellebø has experience at both large pharma ...
15 September 2014
Ashley Yeo

A blissful summer – albeit now swiftly receding – free of political sparring over the proposed twin EU medtech regulations? Or did you miss the duck and weave, the EU medtech industry being pummelled but still standing and coming out fighting again, ...

22 August 2014
Ashley Yeo

The case for a more concerted move towards adoption of digital pathology is stronger than ever. That is the impression left by Sara Dalmasso , GE Healthcare ’s UK-based general manager for digital pathology Europe, who says that the cost, accuracy ...

 
22 September 2014
Madeleine Armstrong

Many companies and researchers are trying to develop a blood test for Alzheimer’s disease – but Norway’s Pre Diagnostics is taking a different approach that it believes will give it the edge over its rivals. Clinica spoke to chief scientific officer ...

22 September 2014
Mike Fisher, Wendy Alderton

Hematological cancers are the only cancers where the matrix in which the tumour cells reside is accessible without a biopsy. Coupling this with the maturation of longitudinal serum banks allows the study of biomarkers and targets in pre-disease ...

19 September 2014
Amanda Maxwell

Companies are now being caught out because aspects of the European Commission Recommendation 2013/473/EU are being enforced by notified bodies during routine audits, even though they are not law. Rod Ruston, director of Priory Analysts consultancy ...

 
22 September 2014
Madeleine Armstrong

Many companies and researchers are trying to develop a blood test for Alzheimer’s disease – but Norway’s Pre Diagnostics is taking a different approach that it believes will give it the edge over its rivals. Clinica spoke to chief scientific officer ...

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

There is a perceptible buzz these days around the subjects o fmHealth and healthcare apps. But how fast is the technology in these areas changing? How are the regulators going to police this market when it starts to really take off? Amanda Maxwell ...

 
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 ...

 
11 September 2014

Specialty area(s): Motion management for radiation therapy Based in: London, UK Founded in: 2001 No. of employees: 54 Total investment received to date: £6.4m ($10.3m) Investors: Includes YFM Equity Partners

 
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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