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25 October 2014

 
24 October 2014
The European Commission has rejected Parliament’s proposal that notified bodies should not be obliged to consult a pharmaceutical authority as part of the conformity assessment on companion diagnostics. The commission has just published its ...
24 October 2014
China has traditionally been a key exporter of low-risk devices to the US but the US FDA is now expecting to see a heavier, incoming flow of China-manufactured, Class 3 devices. In response, both the US agency and the China FDA are making moves to ...
23 October 2014
The maker of the only FDA-approved device for improving vision in patients with end-stage age-related macular degeneration is scaling up its sales efforts, as it awaits a reimbursement ruling that could broaden its market dramatically. There is ...
23 October 2014
The medtech purchasing environment is changing and medtech companies need to adapt the way they differentiate their products. In preparation for its 2014 Pulse of the Industry medtech report, Differentiating Differently, Ernst & Young went out to ...
 
24 October 2014
The European Commission has rejected Parliament’s proposal that notified bodies should not be obliged to consult a pharmaceutical authority as part of the conformity assessment on companion diagnostics. The commission has just published its ...
22 October 2014
bioMérieux’s third quarter was “broadly in line” with expectations, according to Jefferies analyst Peter Welford. Q3 sales of €412m ($523m) grew 6% year-on-year, with 2.3% organic growth similar to his prediction of 2.6%, but “shy of +3.1% ...
22 October 2014
A Swedish start-up with a ceramic bone implant is one step closer to carving itself a space in the €1.5m ($1.9m) bone repair market. OssDsign has received 510(k) clearance from the US FDA to commercialize its bioceramic burr hole plug, Cranioplug. ...
21 October 2014
Genome sequencing firm Illumina beat analysts’ expectations in its third quarter, with sales of $481m, up 35% year-on-year and 7% above the consensus estimate of $451m. This was the highest year-on-year growth since Q2 2011 and marked the twelfth ...
 
24 October 2014
Cancer and dementia research in the UK, including studies in imaging technologies and genomics, is to receive a funding boost of around £230m ($369m) under a new clinical research initiative. The UK's Chancellor of the Exchequer George Osborne ...
24 October 2014
Edwards Lifesciences’ third-quarter results “dramatically surpassed already lofty expectations,” according to Jefferies analyst Raj Denhoy. The firm posted 23% year-on-year sales growth, driven by a 55% increase in its transcatheter heart valves ...
23 October 2014
The medtech purchasing environment is changing and medtech companies need to adapt the way they differentiate their products. In preparation for its 2014 Pulse of the Industry medtech report, Differentiating Differently, Ernst & Young went out to ...
23 October 2014
CR Bard had a good third quarter marked by “strong underlying US growth,” according to Jefferies analyst Raj Denhoy. Overall, Q3 sales grew 9% to $830m, $11m higher than analysts had expected. US revenues increased 13% year-on-year to $565.4m, while ...
 
24 October 2014
The European Commission has rejected Parliament’s proposal that notified bodies should not be obliged to consult a pharmaceutical authority as part of the conformity assessment on companion diagnostics. The commission has just published its ...
24 October 2014
China has traditionally been a key exporter of low-risk devices to the US but the US FDA is now expecting to see a heavier, incoming flow of China-manufactured, Class 3 devices. In response, both the US agency and the China FDA are making moves to ...
24 October 2014
Cancer and dementia research in the UK, including studies in imaging technologies and genomics, is to receive a funding boost of around £230m ($369m) under a new clinical research initiative. The UK's Chancellor of the Exchequer George Osborne ...
22 October 2014
Oversight of medical device and drug policy in the EU is to remain with the European Commission’s health directorate (DG Sanco), and not with the industry directorate (DG ENTR). The news was announced just before the European Parliament today voted ...
 
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 ...

 
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 ...
 BRUSSELS BEAT: There’s an EU will on UDI, but there’s no way...   Q3 EARNINGS: OCD sale dents JNJ's device business...
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 ...
09 October 2014
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 ...
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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22 September 2014
Madeleine Armstrong

Many companies and researchers are trying to develop a blood test for Alzheimer’s disease – but Norway’s Pre Diagnostics is taking a different approach that it believes will give it the edge over its rivals. Clinica spoke to chief scientific officer ...

 
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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