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31 January 2015

 
29 January 2015
The days when an intermittent update between medical device manufacturers and notified bodies in the EU was sufficient are over. In the new era of unannounced audits, it is more important now than ever for manufacturers to invest in a timely, ...
28 January 2015
EU medtech industry association, COCIR, is lobbying the Council of the EU, via its Permanent Representations, using arguments that are laid out in its recently-revised high-level contribution on the proposed Medical Device Regulation (MDR). Notably, ...
27 January 2015
Medtronic’s $42.9bn takeover of Covidien passed the finish line on 26 January, after the deal – said to be the largest corporate inversion ever – got its final sign-off from the Irish High Court. The new Medtronic PLC will be legally domiciled in ...
26 January 2015
For more than 50 years, medical devices in Japan were regulated the same way as drugs. But all this changed at the end of last year when a new legislation came into force, enabling devices to finally have a separate regulatory route which would ...
 
27 January 2015
Myriad Genetics has settled four more patent wrangles over its BRCA gene mutation tests, with Pathway Genomics, Invitae, Ambry Genetics and LabCorp. Ever since the US Supreme Court ruled in June 2013 that human genes cannot be patented because they ...
26 January 2015
The US FDA's device center says it is well ahead of the goals it set for itself to improve the investigational device exemption review process, but it still has aggressive improvements planned for the current year. The number of IDE studies that ...
23 January 2015
Check-Cap has become the latest firm to target an initial public offering: it plans to sell 1.2 million shares at $10-12 each, giving it around $13m at the midpoint. If successful, it will trade on the Nasdaq under the ticker symbol CHEK. The Mount ...
23 January 2015
Manufacturers of drug/device combination products need to consider carefully their reimbursement position and be prepared to collect the data necessary to support reimbursement submissions. Where a price premium is sought compared to current ...
 
30 January 2015
Quest Diagnostics finished the year strongly, with its fourth quarter beating analyst expectations. Q4 sales of $1.88bn increased 7% year-on-year, marking the firm’s third consecutive quarter of growth, and were above analyst consensus of $1.85bn. ...
29 January 2015
Hologic’s turnaround is “well underway,” as the firm beat analyst expectations for both revenues and earnings during its first quarter, according to Jefferies analyst Raj Denhoy. Q1 sales of $652.8m increased 7% year-on-year and were $20m above ...
28 January 2015
Not long after swapping its CEO, Getinge has reported a “solid” fourth quarter. What’s more, its 2015 outlooks “suggests a sustainable recovery in sales/profitability,” said Jefferies analyst Martin Brunninger. In other good news, the Swedish firm ...
28 January 2015
As expected, the US FDA has approved Abiomed’s Impella RP percutaneous heart pump under a humanitarian device exemption for right-sided heart failure. The firm also reported 34% sales growth in its third fiscal quarter, at $62.0m, as worldwide ...
 
29 January 2015
The days when an intermittent update between medical device manufacturers and notified bodies in the EU was sufficient are over. In the new era of unannounced audits, it is more important now than ever for manufacturers to invest in a timely, ...
28 January 2015
EU medtech industry association, COCIR, is lobbying the Council of the EU, via its Permanent Representations, using arguments that are laid out in its recently-revised high-level contribution on the proposed Medical Device Regulation (MDR). Notably, ...
26 January 2015
The US FDA's device center says it is well ahead of the goals it set for itself to improve the investigational device exemption review process, but it still has aggressive improvements planned for the current year. The number of IDE studies that ...
26 January 2015
For more than 50 years, medical devices in Japan were regulated the same way as drugs. But all this changed at the end of last year when a new legislation came into force, enabling devices to finally have a separate regulatory route which would ...
 
Keltjens to step in at JenaValve as Drachman departs David Drachman has resigned as CEO of German transcatheter aortic valve developer JenaValve after six months, and will be replaced by industry ...
Nextremity appoints ex-Zimmer, DePuy exec CEO Emerging orthopedic firm Nextremity Solutions has appointed Nick Deeter, who has previously worked for ortho giants Zimmer and DePuy, CEO and chair. ...
Paul Mieyal comes back to Nephros Paul Mieyal has returned to lead hemodialysis filtration specialist Nephros, filling the role of acting president, acting CEO and acting chief ...
30 January 2015
Ashley Yeo

Who wields the power in the delivery of healthcare? Not the government, not the regulators and not the doctors – not this week in Germany, in any case. A Dear Patient letter from the managers of the Westphalia-Lippe Association of Statutory Health ...

29 January 2015
Ashley Yeo

Undaunted by last autumn’s independent analyst report that cast doubt on US medical device manufacturers‘ claims that the 2.3% device sales tax is seriously damaging to the local industry, AdvaMed has returned fire. In its second annual survey of ...

 
30 January 2015
Who wields the power in the delivery of healthcare? Not the government, not the regulators and not the doctors – not this week in Germany, in any case. A Dear Patient letter from the managers of the Westphalia-Lippe Association of Statutory Health ...
 German uni clinic deaths add to case for better patient scre...   REIMBURSEMENT UNRAVELLED: EU challenges of drug/device combi...
29 January 2015
Undaunted by last autumn’s independent analyst report that cast doubt on US medical device manufacturers‘ claims that the 2.3% device sales tax is seriously damaging to the local industry, AdvaMed has returned fire. In its second annual survey of ...
27 January 2015
The tragedy of the Ebola virus is not just its broad scale human consequences, but that it was avoidable. Easy to be wiseafter the event, and lazily easy to ascribe all blame to those whose task is to manage finite preventive care resources. But ...
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 ...

 
15 January 2015

Specialty area(s): Noninvasive detection of malignant melanoma Based in: Stockholm, Sweden Founded in: 1998 No. of employees: 15 Total investment received to date: Over SEK200m ($25m) Investors: SEB, Fouriertransform, Omega Funds

 
 
 
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