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RECENT TWEETS    
29 July 2015

 
28 July 2015
South African health minister Aaron Motsoaledi has taken the next step in establishing the national eHealth system in South Africa by setting up a Ministerial Advisory Committee that will draw membership from the private sector and public offices. ...
27 July 2015
A new US Senate bill, the Combination Product Regulatory Fairness Act of 2015, is intended to streamline device/drug combination registrations at the FDA by letting the agency rely on prior PMAs and approved drug findings to support new product ...
24 July 2015
Boston Scientific last week launched its first trial for a fully bioresorbable coronary scaffold, but executives have suggested that the firm is treading carefully to see if it offers sufficient advantage over Boston's successful Synergy stent, ...
23 July 2015
The International Medical Device Regulators Forum is seeking feedback on the issues and challenges that companies manufacturing and marketing standalone medical device software face in understanding and applying guidance documents issued by the ...
 
24 July 2015
Boston Scientific last week launched its first trial for a fully bioresorbable coronary scaffold, but executives have suggested that the firm is treading carefully to see if it offers sufficient advantage over Boston's successful Synergy stent, ...
23 July 2015
The International Medical Device Regulators Forum is seeking feedback on the issues and challenges that companies manufacturing and marketing standalone medical device software face in understanding and applying guidance documents issued by the ...
22 July 2015
St Jude Medical plans to be the first of the big cardiovascular device companies to sell ventricular assist devices after agreeing to buy leading VAD-maker Thoratec. But there is a possibility that another rival might swoop in to scupper the deal. ...
21 July 2015
A few weeks ago, St. Jude Medical marked the one-year anniversary of its acquisition of CardioMEMS, developer of the CardioMEMS HF System, which became the first US FDA-approved heart failure monitor proven to significantly reduce HF hospital ...
 
28 July 2015
NuVasive Inc. has reached an agreement to pay the US federal government $13.5m plus fees and interest to settle an investigation into allegations of Medicare fraud. The spine device firm announced the definitive settlement with the Department of ...
24 July 2015
Boston Scientific last week launched its first trial for a fully bioresorbable coronary scaffold, but executives have suggested that the firm is treading carefully to see if it offers sufficient advantage over Boston's successful Synergy stent, ...
23 July 2015
St Jude Medical's second-quarter 2015 sales were up 6% year-over-year on a constant currency basis, driven by strong growth in atrial fibrillation, neuromodulation and vascular products, the company reported July 22. Net earnings in the quarter ...
23 July 2015
Abbott Laboratories has submitted its application for US premarket approval for its everolimus-eluting Absorb bioresorbable vascular scaffold. A company spokesman confirmed to The Gray Sheet, Clinica's sister publication, that the submission was ...
 
28 July 2015
South African health minister Aaron Motsoaledi has taken the next step in establishing the national eHealth system in South Africa by setting up a Ministerial Advisory Committee that will draw membership from the private sector and public offices. ...
28 July 2015
Medical device manufacturers are concerned about a lack of globally harmonized standards for good clinical practices (GCPs), which they say could cause problems for a guidance that the FDA has drafted on studies conducted outside the US. Industry is ...
27 July 2015
A new US Senate bill, the Combination Product Regulatory Fairness Act of 2015, is intended to streamline device/drug combination registrations at the FDA by letting the agency rely on prior PMAs and approved drug findings to support new product ...
27 July 2015
Notified bodies in the EU are being given more time to sign up to a pilot program that is being run by the International Medical Device Regulators Forum to test a common electronic submission format for reviewing device submissions. So far, only ...
 
BSI active implantable expert joins MedPass David Francis, former global head of active implantable devices at notified body BSI, has joined France-based medical device consultancy MedPass, as ...
IlluminOss reels in former Zimmer exec to head sales expansion Former Zimmer veteran Clive Ridgewell has joined IlluminOss Medical, a privately-held company focused on minimally invasive orthopedic fracture ...
Abingworth brings in new leadership Abingworth, the international investment group focused on healthcare and life sciences, has appointed Tim Haines and Kurt von Emster joint managing ...
20 July 2015
Ashley Yeo

The height of summer in Europe it may be, but EU medtech industry leaders are not giving way to the holiday feeling just yet – not with the resumption of high level talks on the proposed Medical Device Regulation (MDR) and sister IVDR just around ...

16 July 2015
Ashley Yeo

Now that TÜV Rheinland, the notified body of the French company found to have fraudulently manufactured and sold breast implants with inferior grade silicon content, has been cleared of any wrongdoing in the French appeal courts, what are the ...

 
20 July 2015
Ashley Yeo

The height of summer in Europe it may be, but EU medtech industry leaders are not giving way to the holiday feeling just yet – not with the resumption of high level talks on the proposed Medical Device Regulation (MDR) and sister IVDR just around ...

16 July 2015
Ashley Yeo

Now that TÜV Rheinland, the notified body of the French company found to have fraudulently manufactured and sold breast implants with inferior grade silicon content, has been cleared of any wrongdoing in the French appeal courts, what are the ...

23 June 2015
Tina Tan

Innovation is critical for medtech companies to stay ahead of the game and ensure continuous growth. But sometimes, this innovation does not necessarily have to come in the form of new technologies. Neil Mesher, managing director of Philips ...

 
23 June 2015
Tina Tan

Innovation is critical for medtech companies to stay ahead of the game and ensure continuous growth. But sometimes, this innovation does not necessarily have to come in the form of new technologies. Neil Mesher, managing director of Philips ...

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

 
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 ...

 
20 July 2015

Specialty area(s): Endovascular devices for treating cerebral aneurysm and peripheral vascular disease Based in: Olathe, Kansas, US Founded in: 2011 No. of employees: 2 Total investment received to date: $7m Investors: Kansas Bioscience ...

 
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 ...

 
 
EVENTS
16 September 2015
Hotel Palace Berlin, Germany
27 October 2015
Maritim proArte Hotel, Berlin, Germany
03 November 2015
Kempinski Hotel Bristol Berlin, Berlin, Germany    
 
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