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31 August 2014

 
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
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,” ...
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
With under a month before US requirements on unique device identification (UDI) come into force, the FDA has issued a Q&A document that addresses questions it frequently receives on the topic. The document summarizes key aspects of the UDI ...
 
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 ...
 
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 ...
 
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 ...
28 August 2014
With under a month before US requirements on unique device identification (UDI) come into force, the FDA has issued a Q&A document that addresses questions it frequently receives on the topic. The document summarizes key aspects of the UDI ...
28 August 2014
The European Commission is launching an internal EU test of the final market authorization tables of contents (ToC) for medical devices and IVDs that was recently posted by the International Medical Device Regulators Forum. These documents , ...
27 August 2014
The US FDA has issued revised draft guidance on its de novo process that aims to speed the reclassification of new types of devices that present a relatively low isk and for which no predicates are available. The updated guidance, when finalized, ...
 
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 ...

 
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 August 2014
Ideas remain only ideas, no matter how good, unless they are nurtured in the right environment and developed into commercializable products. Helping to transform promising medical inventions emerging from Israel – one of the world’s technology ...
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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27 August 2014
Madeleine Armstrong

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 ...

 
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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