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01 November 2014

 
31 October 2014
With the 19 th annual Asian Harmonization Working Party meeting just around the corner, this topic kicked off the second session of Clinica’s Access All Asia* regulatory forum. This year’s AHWP conference marks a changeover in the AHWP officials ...
31 October 2014
Responsibility for EU medical devices policy is moving from the European Commission’s health directorate (DG Sanco) to the new industry directorate (DG ENTR) after all, Clinica has learnt. The confirmation, which came from a commission ...
31 October 2014
France has seen the worst of the recent healthcare products scandals and the medtech industry has had to contend with reorganization and refocusing at its national authority. Here Alexandre Regniault and Anne-Catherine Perroy-Maillols explain how ...
30 October 2014
In the fifth instalment of Clinica’s new reimbursement series, Dr Mark Charny explains that careful and detailed consideration of the reimbursement, prescribing and purchasing regulations in each market is required to develop a coherent marketing ...
 
30 October 2014
Abbott Laboratories, already among the most diversified major medtech companies, is now entering the electrophysiology space. With the acquisition of Topera Medical and the rights to buy Advanced Cardiac Therapeutics, Abbott is going after the ...
30 October 2014
Laboratory Corporation of America (LabCorp) had a solid third-quarter, according to Goldman Sachs’ Isaac Ro, again beating analyst predictions. Sales of $1.55bn grew 6% year-on-year and were above consensus of $1.50bn; while adjusted earnings of ...
29 October 2014
A small group of experts is to conduct an independent assessment of Australia's Therapeutic Goods Administration with a view to streamlining the agency's regulatory processes for medicines and medical devices, improving access to medicines, and ...
29 October 2014
Alere has agreed to sell its health services unit, Alere Health, to United Health subsidiary Optum for $600m in cash. The divestment is part of Alere’s ongoing restructuring after a troubled time: last year, a group of rebel shareholders tried – ...
 
31 October 2014
Ventricular assist device number-two player HeartWare International saw sales increase 25% during its third quarter; but it swung back into the red. The firm reported a net loss of $7.4m, narrowed from $11.4m in Q3 2013, but a setback after it made ...
30 October 2014
Abbott Laboratories, already among the most diversified major medtech companies, is now entering the electrophysiology space. With the acquisition of Topera Medical and the rights to buy Advanced Cardiac Therapeutics, Abbott is going after the ...
30 October 2014
Dutch molecular diagnostics specialist Qiagen posted an in-line third quarter, with sales of $336.8m and adjusted earnings of $0.27 per share bang on analyst consensus. However, the firm is facing a challenging human papillomavirus (HPV) testing ...
30 October 2014
Laboratory Corporation of America (LabCorp) had a solid third-quarter, according to Goldman Sachs’ Isaac Ro, again beating analyst predictions. Sales of $1.55bn grew 6% year-on-year and were above consensus of $1.50bn; while adjusted earnings of ...
 
31 October 2014
With the 19 th annual Asian Harmonization Working Party meeting just around the corner, this topic kicked off the second session of Clinica’s Access All Asia* regulatory forum. This year’s AHWP conference marks a changeover in the AHWP officials ...
31 October 2014
Responsibility for EU medical devices policy is moving from the European Commission’s health directorate (DG Sanco) to the new industry directorate (DG ENTR) after all, Clinica has learnt. The confirmation, which came from a commission ...
31 October 2014
The NHS Five Year Forward View (5YFV), released last week by NHS England chief executive Simon Stevens, is in some ways an outcomes-focused grand vision of how care should be delivered through NHS England’s multiple and various structures. But it ...
31 October 2014
France has seen the worst of the recent healthcare products scandals and the medtech industry has had to contend with reorganization and refocusing at its national authority. Here Alexandre Regniault and Anne-Catherine Perroy-Maillols explain how ...
 
Amedica gets surgical expertise with new CEO Orthopedic firm Amedica has appointed existing chair and board member Sonny Bal president and CEO. He replaces Eric Olson, who has been heading up ...
Thoratec goes back to the future with CEO appointment Keith Grossman has retaken the helm of left-ventricular-assist-device manufacturer Thoratec after an eight-and-a-half year hiatus. Mr Grossman has ...
Insulet bags veteran Patrick Sullivan as new CEO Insulin pump specialist Insulet has appointed Patrick Sullivan CEO, with long-time leader Duane DeSisto retiring after 13 years with the firm. ...
23 October 2014
Ashley Yeo

For all the high regard in which the English NHS is held, domestically and, more dispassionately, outside the UK (eg the recent Commonwealth Fund ’s international health systems ranking), the consensus has long been that current and future ...

09 October 2014
Peter Charlish

Personalized medicine may not yet be a reality but, as a meeting of the Society for Medicines Research heard in London last week, considerable progress has nonetheless already been made towards that goal. In the UK, for example, a number of ...

 
31 October 2014
Johnson & Johnson has long been an investor in early-stage science, and the company is increasing its geographic reach with the launch of a new J-Labs incubator in Houston, Texas. The incubator is part of its J-Labs offering, formerly known as ...
23 October 2014
For all the high regard in which the English NHS is held, domestically and, more dispassionately, outside the UK (eg the recent Commonwealth Fund ’s international health systems ranking), the consensus has long been that current and future ...
22 October 2014
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 ...
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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31 October 2014
Madeleine Armstrong

Johnson & Johnson has long been an investor in early-stage science, and the company is increasing its geographic reach with the launch of a new J-Labs incubator in Houston, Texas. The incubator is part of its J-Labs offering, formerly known as ...

 
21 October 2014

Clinica’s Medtech Ventures: Origin Sciences Specialty area(s): Gastrointestinal disease detection and monitoring Based in: Cambridge, UK Founded in: 2004 No. of employees: 7 Total investment received to date:  £7.5m ($12.0m) Investors:  Animatrix ...

 
 
 
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