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02 September 2014

 
02 September 2014
Manufacturers must be sure to follow a careful process of verifying and authenticating auditors at the start of an unannounced notified body audit to ensure that they are who they claim to be. That is the advice of German notified body TÜV SÜD in a ...
02 September 2014
Vagal nerve stimulation (VNS) for heart failure promised to be a big topic at this year’s European Society of Cardiology (ESC) meeting in Barcelona, and it did not disappoint – but perhaps for the wrong reasons. The meeting had barely begun before ...
01 September 2014
As the traditional summer holiday period comes to an end in Europe and medtech executives and return to their office desks, the biggest thing on their minds will be how the future new regulations on medical devices and IVDs will change their way of ...
29 August 2014
Japan has announced ambitious new plans to speed up the development and evaluation of locally developed innovative pharmaceuticals, medical devices and regenerative medicines. The plans feed into Japan's aims to establish the country as the world ...
 
02 September 2014
Vagal nerve stimulation (VNS) for heart failure promised to be a big topic at this year’s European Society of Cardiology (ESC) meeting in Barcelona, and it did not disappoint – but perhaps for the wrong reasons. The meeting had barely begun before ...
01 September 2014
The Brazilian regulatory agency, Anvisa, has drawn up proposals for streamlining and accelerating the approval processes for applications to conduct clinical trials of new medical devices and drugs. The proposals are open for public consultation ...
29 August 2014
Japan has announced ambitious new plans to speed up the development and evaluation of locally developed innovative pharmaceuticals, medical devices and regenerative medicines. The plans feed into Japan's aims to establish the country as the world ...
29 August 2014
With the European Society of Cardiology’s (ESC’s) annual meeting starting on 30 August in Barcelona, Spain, Clinica takes a look at some of the key developments expected at the meeting. Vagus nerve stimulation (VNS) for heart failure is set to be a ...
 
29 August 2014
The trend for big technology companies getting increasingly involved in the medical device arena isn’t going away anytime soon, and it could have a big impact on the sector. “I think it’s going to change the industry significantly in years to come,” ...
29 August 2014
The summer M&A flurry is showing no sign of slowing as August comes to a close: the latest deal, in diagnostics, sees Germany’s Orgentec Diagnostika acquiring Corgenix Medical for $0.27 per share or around $16m in total. Denver, Colorado-based ...
28 August 2014
The last three months have seen a flurry of M&A activity and as summer starts drawing to a close, it looks like the medtech players are rushing to bag some end-of-season deals. Covidien’s appetite for bolt-on acquisitions has not waned. Just under ...
28 August 2014
Californian company NeuroSigma has filed for a $50m initial public offering to fund development of its Monarch external trigeminal nerve stimulation system (eTNS) system for epilepsy and depression. The firm, which plans to trade on the Nasdaq under ...
 
02 September 2014
Manufacturers must be sure to follow a careful process of verifying and authenticating auditors at the start of an unannounced notified body audit to ensure that they are who they claim to be. That is the advice of German notified body TÜV SÜD in a ...
01 September 2014
The Brazilian regulatory agency, Anvisa, has drawn up proposals for streamlining and accelerating the approval processes for applications to conduct clinical trials of new medical devices and drugs. The proposals are open for public consultation ...
01 September 2014
The US National Institutes of Health issued a final policy about sharing genomic data, which will apply to all federal government-funded large-scale human and non-human projects that generate such information, including research conducted with the ...
01 September 2014
As the traditional summer holiday period comes to an end in Europe and medtech executives and return to their office desks, the biggest thing on their minds will be how the future new regulations on medical devices and IVDs will change their way of ...
 
Ex-Edwards exec Stefan Schreck becomes JenaValve CTO Not long after bagging a new CEO, German transcatheter aortic valve developer JenaValve has appointed Stefan Schreck chief technology officer. Dr ...
Former SNN exec to head up Rex Bionics Robotic exoskeleton developer Rex Bionics has appointed Crispin Simon CEO; when Mr Simon joins in October 2014, current chief Jeremy Curnock Cook ...
CryoLife makes Medtronic executive Mackin CEO CryoLife, which specializes in providing preserved human cardiac and vascular tissues for surgery, has appointed James Patrick (Pat) Mackin president ...
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 ...

18 August 2014
Amanda Maxwell

News that the Australian Therapeutic Goods Administration is to re-audit all medical devices in Australia that were previously assessed by a group of eight specific notified bodies could represent a global challenge to the integrity of the current ...

 
02 September 2014
23andMe’s announcement earlier this month that it had teamed up with pharmaceutical firm Pfizer in inflammatory bowel disease (IBD) could pave the way for the expansion of personalized medicine into a new area. So far, the personalized approach has ...
27 August 2014
Would you want to know if you had an incurable disease like Alzheimer’s? According to a survey funded by GE Healthcare, 74% of people worldwide would want the bad news, even if the treatment options are limited. The results, from 10,000 people in ...
22 August 2014
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 ...
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 ...

 
“Beyond Compliance”: a self regulation tool to add strength to the CE marking – podcast
16 December 2013
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02 September 2014
Madeleine Armstrong

23andMe’s announcement earlier this month that it had teamed up with pharmaceutical firm Pfizer in inflammatory bowel disease (IBD) could pave the way for the expansion of personalized medicine into a new area. So far, the personalized approach has ...

 
05 August 2014

Specialty area(s): Alzheimer’s disease diagnostics Based in: Sacramento, California, US Founded in: 2010 No. of employees: 10 Total investment received to date: Around $4.5m Investors: Undisclosed

 
 
 
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