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Featured
20 June 2013

 
New US FDA program to help determine if device trials will lead to market approval
19 June 2013
The US Food and Drug Administration is inviting feedback on its plans to create a new voluntary process that would allow device trial sponsors to determine whether their pivotal study design would support a marketing application if it is ...
AngloNordic hot picks: from DBS steering to IBS diagnosis
19 June 2013
The AngloNordic Medtech Conference, held in London, UK on 12 June, highlighted several companies with promising technologies, in sectors as diverse as in vitro diagnostics and deep brain stimulation. The highlights included: Sapiens Steering Brain ...
Medtronic Infuse data do not enthuse
18 June 2013
The much-awaited results of the study into Medtronic’s troubled Infuse bone graft are out and they have so far left analysts unimpressed. Two years ago, in a bid to stem bad publicity that linked Infuse with serious side effects such as cancer, ...
US 510(k) modification policy “needs strengthening, not radical overhaul”
18 June 2013
The US medtech industry says that the process by which medical device companies file submissions for modifications to existing 510(k)-registered devices does not need major change. The US FDA is currently reviewing the process and is soliciting ...
 
Don’t treat us like pharma on additional monitoring symbol, says Australian medtech industry
20 June 2013
The Australian medtech industry association, the MTAA, has objected to proposals by the Therapeutic Goods Administration to introduce a black triangle or other symbol for new medical devices and on existing devices approved for new uses. It points ...
New US FDA program to help determine if device trials will lead to market approval
19 June 2013
The US Food and Drug Administration is inviting feedback on its plans to create a new voluntary process that would allow device trial sponsors to determine whether their pivotal study design would support a marketing application if it is ...
AngloNordic hot picks: from DBS steering to IBS diagnosis
19 June 2013
The AngloNordic Medtech Conference, held in London, UK on 12 June, highlighted several companies with promising technologies, in sectors as diverse as in vitro diagnostics and deep brain stimulation. The highlights included: Sapiens Steering Brain ...
Siemens, J&J link up for heart drug companion Dx
19 June 2013
In a bid to build up its personalized medicine business, Siemens has agreed to develop a companion diagnostic for a heart failure drug being investigated by Johnson & Johnson’s Janssen Pharmaceutica. Siemens will work with Janssen to design an ...
 
IDS emerges out of challenging FY2013 more robust
18 June 2013
The lowdown Fiscal 2013 was a challenging year for UK-listed IVD firm Immunodiagnostic Systems (IDS), as reflected in the company’s full-year results which saw revenue and adjusted pre-tax profit decline. While slower growth in its core vitamin D ...
One down, two to go: Medtronic scores small TAVI win against Edwards
18 June 2013
Medtronic has been cleared by a German court of infringing a patent owned by Edwards that relates to transcatheter aortic valve implantation (TAVI) technology. The ruling is a surprising twist in an ongoing battle between the two TAVI rivals; ...
Myriad facing competition post-SCOTUS, as myRisk doubts raised
14 June 2013
Myriad Genetics is already facing competition from rivals keen to cash in on the recent US Supreme Court decision that DNA is not patentable, but complementary DNA (cDNA) is. The company was defending its patents on the BRCA1 and BRCA2 genes, which ...
Life continues Korean expansion
14 June 2013
Life Technologies, which itself is soon to become part of Thermo Fisher Scientific, has bought its Korean distribution partner Life Science Korea (LSK). This is the second such deal for Life in the past few months: in April, it acquired Korean ...
 
New US FDA program to help determine if device trials will lead to market approval
19 June 2013
The US Food and Drug Administration is inviting feedback on its plans to create a new voluntary process that would allow device trial sponsors to determine whether their pivotal study design would support a marketing application if it is ...
US 510(k) modification policy “needs strengthening, not radical overhaul”
18 June 2013
The US medtech industry says that the process by which medical device companies file submissions for modifications to existing 510(k)-registered devices does not need major change. The US FDA is currently reviewing the process and is soliciting ...
India and NICE to collaborate on 'evidence-informed' healthcare
18 June 2013
India's health and family welfare ministry and the National Institute for Health and Clinical Excellence ( NICE ) in England and Wales plan to work together to provide a framework for strategic and technical co-operation between the two countries on ...
Gold still there, just hidden, say under-pressure German life sci firms
18 June 2013
2012 was not a vintage year for German medical devices and IVDs sales, with the markets shrinking by 0.8%, to €7.2 billion ($9.5 billion), and 1.2%, to €2.2 billion, respectively. That is according to the Life Sciences Research (LSR) branch of the ...
 
PEOPLE
DBV names new marketing chief Veronique Foutel DBV Technologies , a French company developing transdermal drug delivery systems for treating food allergies, has appointed ...
Atossa lures Carbonaro with $1.1m stock option Atossa Genetics, a developer of breast cancer predictive tests, has appointed Peter Carbonaro to the newly created role of senior vice-president of ...
Atlas Genetics adds R&D expertise UK IVD firm Atlas Genetics has appointed Daniel Adlerstein director of research and development. Mr Adlerstein joins the Bath-based company from ...
>> More People News...
Drug/device combinations rising: could EMA cope?
17 June 2013
Amanda Maxwell

Figures from a recent survey of the EU regulatory landscape should help determine the European Medicines Agency’s capacity to take on the responsibility for premarket authorization of some high-risk and innovative medical devices, including ...

 
Why do medtech SMEs and startups fail so frequently?
19 June 2013
Jon Lewis

Jon Lewis, Chief Innovation Officer of Plextek Consulting takes a look at the market factors which prevent medical SMEs making the step up from disruptive innovators to successful businesses It’s difficult to definitively say just how many startups ...

Drug/device combinations rising: could EMA cope?
17 June 2013
Amanda Maxwell

Figures from a recent survey of the EU regulatory landscape should help determine the European Medicines Agency’s capacity to take on the responsibility for premarket authorization of some high-risk and innovative medical devices, including ...

EU MDR/MDR-lite seen through a German lens
14 June 2013
Ashley Yeo

One month out from the 10 July vote by the European Parliament ’s ENVI committee on its proposed Medical Devices Regulation (MDR) amendments – some 300 all told, after grouping the original 900 or more – the German industry arranged one final big ...

 
INTERVIEW: COOKing up a storm amidst testing times
07 May 2013
Madeleine Armstrong

Kem Hawkins “What’s the most memorable answer anyone’s given you during an interview?” asks Cook Medical president Kem Hawkins, eyes twinkling with amusement. Suddenly the tables have turned, and Clinica is the interviewee, not the interviewer. It’s ...

 
VIDEOS/PODCASTS
Clinica Chat: Could renal denervation therapy could be expanded to encompass a larger patient population
11 June 2013
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EP medtech reg debate: Informed consent in EU IVD Regulation – will missing topic need tackling?
11 March 2013
Amanda Maxwell

The issue of informed consent for genetic tests dominated discussions at the European Parliament on February 26 during the second half of the meeting, dedicated to the European Commission’s proposed In Vitro Diagnostics Regulations. The tempo of the ...

 
Overcoming the challenges of cancer diagnostics development
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 ...

 
Clinica's MedTech Ventures: Issue 62
22 April 2013

Next-generation drug-eluting stents, novel drug polymer conjugates and neurostimulation for severe headaches are featured in this edition of Medtech Ventures.

 
Organovo's bioprinter for new tissue and EStimME expands into middle ear drug delivery
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
Tech Tour Healthtech Summit
25 June 2013
London, UK
Labelling Compliance for Medical Devices & IVDs
09 October 2013
Millennium Gloucester Hotel, London, UK
Life Sciences Israel 2013
16 October 2013
Tel Aviv, Israel
 
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