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29 March 2015

 
27 March 2015
What should companies do if their notified body is de-designated or loses its status in their product area? Bassil Akra, of TŰV-SŰD Product Service, explained to Clinica what the options are in three different situations The current European ...
27 March 2015
Plans to introduce benefit assessments for new high-risk medical technology diagnosis and treatment methods (NUBs) in Germany have put the industry on its guard. A public hearing of the sickness insurance care bill ( Gesetz zur Stärkung der ...
26 March 2015
What are the main challenges for companies when it comes to demonstrating compliance with Japanese medical device requirements, and particularly those that are different to requirements in markets such as the EU? Amanda Maxwell spoke with Eiko ...
25 March 2015
Regulatory guidance is likely to be needed in the area of human factors engineering for healthcare products, including devices, and the UK's Medicines and Healthcare products Regulatory Agency is exploring the best way forward. Amanda Maxwell spoke ...
 
27 March 2015
Johnson & Johnson has joined the list of healthcare’s big hitters that are partnering up with technology giant Google, this time to develop surgical robotics. J&J’s Ethicon surgical division has definitively agreed to collaborate with Google and ...
27 March 2015
Medtronic has made its second acquisition of 2015, purchasing hearing implant developer Sophono for an undisclosed fee. The Boulder, Colorado-based company, which specializes in magnetic, minimally-invasive, low-profile hearing implants, will join ...
26 March 2015
The South Korean government is to invest a total of KRW340bn ($305.4m) in 2015 to support and nurture stem cell and gene therapy firms, in a bid to gain a stronger position in these sectors The move also comes against a background of recent decisive ...
26 March 2015
French spinal technology firm Vexim has seen good growth since it went public in 2012, and is expecting to break even by the end of 2015. CEO Vincent Gardès spoke to Clinica soon after the company reported 69% sales expansion in 2014, to €10.3m ...
 
27 March 2015
Johnson & Johnson has joined the list of healthcare’s big hitters that are partnering up with technology giant Google, this time to develop surgical robotics. J&J’s Ethicon surgical division has definitively agreed to collaborate with Google and ...
27 March 2015
Medtronic has made its second acquisition of 2015, purchasing hearing implant developer Sophono for an undisclosed fee. The Boulder, Colorado-based company, which specializes in magnetic, minimally-invasive, low-profile hearing implants, will join ...
26 March 2015
French spinal technology firm Vexim has seen good growth since it went public in 2012, and is expecting to break even by the end of 2015. CEO Vincent Gardès spoke to Clinica soon after the company reported 69% sales expansion in 2014, to €10.3m ...
25 March 2015
Philips is teaming up with pharma company Janssen to develop a handheld blood test that the firms say will improve the care of patients with neuropsychiatric disorders. Philips will be responsible for the development and manufacturing of the ...
 
27 March 2015
What should companies do if their notified body is de-designated or loses its status in their product area? Bassil Akra, of TŰV-SŰD Product Service, explained to Clinica what the options are in three different situations The current European ...
27 March 2015
Plans to introduce benefit assessments for new high-risk medical technology diagnosis and treatment methods (NUBs) in Germany have put the industry on its guard. A public hearing of the sickness insurance care bill ( Gesetz zur Stärkung der ...
26 March 2015
What are the main challenges for companies when it comes to demonstrating compliance with Japanese medical device requirements, and particularly those that are different to requirements in markets such as the EU? Amanda Maxwell spoke with Eiko ...
25 March 2015
Regulatory guidance is likely to be needed in the area of human factors engineering for healthcare products, including devices, and the UK's Medicines and Healthcare products Regulatory Agency is exploring the best way forward. Amanda Maxwell spoke ...
 
Ex-GE CEO Horgan to lead Align Technology Align Technologies, maker of the Invisalign dental brace, will soon be led by ex-GE Healthcare CEO Joseph Horgan. Mr Horgan will take up the reins on ...
Avedro gets a VC on board As Avedro awaits US FDA approval of its drug-device product for treating complications from refractive surgery, the Massachusetts firm has appointed ...
MitraClip pioneer Ferolyn Powell dies in motorbike accident Ferolyn Powell, best known for leading MitraClip developer Evalve, has died in a motorbike accident while on holidayin Thailand. Ms Powell oversaw ...
24 March 2015
Ashley Yeo

German health minister Hermann Gröhe will use his country’s presidency of the G7 to push new ideas on combating hospital-acquired infection (HAI) and antimicrobial resistance issues when the seven member states meet for their annual summit at ...

17 March 2015
Ashley Yeo

Post-recession and pre-election, the UK in spring 2015 is a land of promise, or at least promises, as far as the adoption of healthcare innovation is concerned. Last week’s official announcement of the Innovative Medicines and Medical Technology ...

 
24 March 2015
German health minister Hermann Gröhe will use his country’s presidency of the G7 to push new ideas on combating hospital-acquired infection (HAI) and antimicrobial resistance issues when the seven member states meet for their annual summit at ...
17 March 2015
Post-recession and pre-election, the UK in spring 2015 is a land of promise, or at least promises, as far as the adoption of healthcare innovation is concerned. Last week’s official announcement of the Innovative Medicines and Medical Technology ...
10 March 2015
Michael Scholl, Karl-Hubertus Gruber and Michael Marquardt* offer a step-by-step guide for medtech companies on how to scale past the sales plateau and move towards continued growth Many mid-sized medtech companies are confronted with a growth ...
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 ...

 
“Beyond Compliance”: a self regulation tool to add strength to the CE marking – podcast
16 December 2013
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21 January 2015
Madeleine Armstrong

Liquid biopsies have shown great promise in detecting and monitoring cancer. One contender, Trovagene, tells Clinica why it believes it has the edge over other companies in the space One of the current goals in oncology is monitoring cancer “from ...

 
19 March 2015

Advanced MR Analytics (AMRA) Specialty area(s): MRI-based fat and muscle composition analysis Based in: Linköping, Sweden Founded in: 2012 No. of employees: 18 Total investment received to date: Around SEK15m ($1.7m) Investors: Industrifonden ...

 
 
 
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