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16 April 2014

 
16 April 2014
Johnson & Johnson’s medical devices and diagnostics (MD&D) division was once again a weak spot, with first-quarter sales flat at $7.1bn. Meanwhile, J&J’s Q1 pharmaceutical sales were up 11% year-on-year at $7.5bn, underlining this unit’s increasing ...
15 April 2014
The US market for energy-based ophthalmic surgical systems totalled nearly $1.7bn in 2013 and is expected to experience healthy, mid-single digit growth over the next half-decade. The use of these systems is predicted to increase in refractive ...
14 April 2014
The long-running court battle between Edwards Lifesciences and Medtronic over their transcatheter aortic valve implant (TAVI) devices has taken an unexpected twist: Edwards has been granted a preliminary US injunction against its rival. The ...
14 April 2014
Up to ten Irish medtech spinout companies could result from an agreement between the Mayo Clinic and the Irish business and R&D promotion agency Enterprise Ireland (EI), which was signed last week in Dublin, Ireland. The co-development and licensing ...
 
16 April 2014
The International Medical Device Regulators Forum is moving closer to finalizing a document on how regulatory authorities recognize or revoke the recognition of auditing organizations that want to take part in the medical device single audit program ...
16 April 2014
The US Food and Drug Administration has issued a further public consultation on the proposed US policy and regulatory framework for health IT applications, including mobile apps. The consultation, announced in a Federal Register notice issued on 7 ...
15 April 2014
Lombard Medical Technologies has postponed its plans for an initial public offering in the US, citing poor market conditions. The UK firm, which specialises in endovascular aneurysm repair (EVAR), had previously said it hoped to raise up to $80m, by ...
15 April 2014
Roche’s diagnostics division put in a solid performance during its first fiscal quarter, with its troubled diabetes division “holding up well,” according to Jefferies analyst Jeffrey Holford. Overall, diagnostics sales were up 2% year-on-year as ...
 
15 April 2014
Lombard Medical Technologies has postponed its plans for an initial public offering in the US, citing poor market conditions. The UK firm, which specialises in endovascular aneurysm repair (EVAR), had previously said it hoped to raise up to $80m, by ...
15 April 2014
Roche’s diagnostics division put in a solid performance during its first fiscal quarter, with its troubled diabetes division “holding up well,” according to Jefferies analyst Jeffrey Holford. Overall, diagnostics sales were up 2% year-on-year as ...
14 April 2014
The long-running court battle between Edwards Lifesciences and Medtronic over their transcatheter aortic valve implant (TAVI) devices has taken an unexpected twist: Edwards has been granted a preliminary US injunction against its rival. The ...
14 April 2014
Covidien has reportedly paid $100m to acquire New Wave Surgical, a developer of laparoendoscopic surgical devices. The deal was announced on New Wave’s website on 28 March but was only widely reported last week, with the $100m fee unconfirmed but ...
 
16 April 2014
The International Medical Device Regulators Forum is moving closer to finalizing a document on how regulatory authorities recognize or revoke the recognition of auditing organizations that want to take part in the medical device single audit program ...
16 April 2014
The US Food and Drug Administration has issued a further public consultation on the proposed US policy and regulatory framework for health IT applications, including mobile apps. The consultation, announced in a Federal Register notice issued on 7 ...
15 April 2014
The Department of Health in the UK is planning to transfer the oversight of the system of issuing certificates of free sale (CFS) to medical device companies to the national medicines and healthcare products regulator, the MHRA, next year. The move ...
14 April 2014
Covidien has reportedly paid $100m to acquire New Wave Surgical, a developer of laparoendoscopic surgical devices. The deal was announced on New Wave’s website on 28 March but was only widely reported last week, with the $100m fee unconfirmed but ...
 
Michael Lewis to chair Cambridge Cognition UK neuropsychological testing company Cambridge Cognition has appointed Michael Lewis nonexecutive chair, replacing Dr Jane Worlock, who is stepping ...
Fujifilm Sonosite makes Fujitani CEO Point-of-care ultrasound specialist Fujifilm Sonosite has appointed Naohiro Fujitani president and CEO after previous incumbent Kevin Goodwin stepped ...
Boston Scientific veteran to head up Pixium French retinal implant specialist Pixium has appointed Khalid Ishaque CEO – he joins from medtech giant Boston Scientific, where he has spent 17 ...
09 April 2014
Ashley Yeo

NHS England chief executive Simon Stevens has wasted little time in putting his mark on the service. In office just over a week, he has already decided to work out of London, not Leeds, as predecessor Sir David Nicholson chose to. His first day ...

04 April 2014
Ashley Yeo

Given the strides he made, Zimmer’s David Dvorak will be a hard act to follow as AdvaMed board chairman: implementation of MDUFA III …issuance of final UDI guidance …putting the device tax legislators on the defensive…the AdvaMed strategic ...

 
09 April 2014
NHS England chief executive Simon Stevens has wasted little time in putting his mark on the service. In office just over a week, he has already decided to work out of London, not Leeds, as predecessor Sir David Nicholson chose to. His first day ...
 Private sector, mobile health & primary screening key to Sou...   Almeida’s AdvaMed agenda prioritises global access, ethics...
04 April 2014
Given the strides he made, Zimmer’s David Dvorak will be a hard act to follow as AdvaMed board chairman: implementation of MDUFA III …issuance of final UDI guidance …putting the device tax legislators on the defensive…the AdvaMed strategic ...
04 April 2014
Now with a few months’ experience under his belt, Germany’s novice healthcare minister Hermann Gröhe has begun moving among the stakeholder groups and getting himself noticed. Last week, he waded into the sickness insurance contributions debate, ...
11 March 2013
Amanda Maxwell

The issue of informed consent for genetic tests dominated discussions at the European Parliament on February 26 during the second half of the meeting, dedicated to the European Commission’s proposed In Vitro Diagnostics Regulations. The tempo of the ...

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

Personalized medicine has long been a buzz phrase in oncology, and it is fair to say that this sector has seen the biggest advances in biomarkers so far. But the strategy, which involves using genetic or other markers to identify patients likely (or ...

 
15 April 2014

Specialty area(s): Protecting brain during transcatheter aortic valve replacement Based in: Santa Rosa, California Founded in: 2009 No. of employees: 25 Total investment received to date: $13m Investors: Private investors

 
 
EVENTS
07 May 2014
Linz, AustriaVenue: Design Center LinzEuropaplatz 1, 4020 Linz, Austria http://www.design-center.at/
14 May 2014
Sheraton Brussels Hotel | Brussels | Belgium
14 May 2014
The Hotel. Brussels, Brussels, Belgium
 
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