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US FDA announces training programmes for device review staff
08 September 2011
The US FDA is introducing two new training programmes to improve the consistency and skill of its medical device unit staff who review pre-market applications. The programmes, designed for reviewers at the FDA’s Center for Devices and Radiological ...
 
US FDA announces training programmes for device review staff
08 September 2011
The US FDA is introducing two new training programmes to improve the consistency and skill of its medical device unit staff who review pre-market applications. The programmes, designed for reviewers at the FDA’s Center for Devices and Radiological ...
US FDA analysis blames poor quality 510(k) submissions for delays in reviews
28 July 2011
The time it takes for the US Food and Drug Administration to review 510(k) applications for clearing medical devices has increased because of industry's failure to file submissions of an adequate quality, an internal analysis by the FDA has ...
 
Ontario expands access to PET scans 05 August 2009

The Canadian industry association representing medical device companies, MEDEC, has welcomed a decision by the Ontario government to add PET scans to the services covered by the Ontario Health Insurance Plan. Historically, Ontario has restricted PET ...

Isotope crisis: US mulls coverage of alternative product
22 June 2009
The US Centers for Medicare and Medicaid Services (CMS) is soliciting comments on whether the radioisotope F-18 sodium fluoride should be reimbursed for use in carrying out PET bone scans. The proposal is a response to the problems affecting the ...
 
Brazil courts Iraq’s “valuable unexplored medtech market”
08 September 2011
Iraqi government officials are scheduled to hold a “technical meeting” with Brazilian medtech industry representatives next month in Brasilia to discuss potential supply co-operation agreements. So said the Brazilian industry association, ...
NICE OKs percutaneous cryotherapy for renal tumours
28 July 2011
The UK’s National Institute for Health and Clinical Excellence (NICE) has approved the use of percutaneous cryotherapy for the treatment of renal tumours. It is one of four techniques appraised in the latest round of NICE’s interventional procedures ...
 
NICE OKs percutaneous cryotherapy for renal tumours
28 July 2011
The UK’s National Institute for Health and Clinical Excellence (NICE) has approved the use of percutaneous cryotherapy for the treatment of renal tumours. It is one of four techniques appraised in the latest round of NICE’s interventional procedures ...
Thermo-Fisher BRAHMS test falls short of NICE "impact evidence" needs
22 June 2011
A highly promising innovative technology, Thermo-Fisher’s BRAHMS copeptin assay test for ruling out a suspected heart attack, has fallen short of full support for its use in the UK’s NHS, as a result of inadequate “clinical practice impact” ...
 
US FDA invites comments on introducing UDIs in electronic data healthcare systems
26 July 2011
The US Food and Drug Administration is to hold a workshop in which it will seek stakeholder feedback on the adoption, implementation and use of unique device identifiers in various health-related electronic data systems. Implementing UDIs in ...
China issues interim provisions on device recalls
22 June 2011
China's State Food and Drug Administration has promulgated interim provisions relating to its management of the medical device recall process. The new provisions, comprising six chapters and 38 articles, are due to come into effect on 1 July. The ...
 
Health technology purchasing: will a single selling strategy work?
10 January 2011
Amanda Maxwell

In the EU, policies relating to healthcare financing, as with procurement and reimbursement, are fragmented and their impact is insufficiently understood. Corinna Sorenson*, research officer in European Health Policy at the London School of ...

 
Successor at Medtronic must choose how to ride out the bumps
23 February 2011
Ashley Yeo

Bill Hawkins’ yet-to-be-appointed successor at Medtronic may be taking over at what is seen as a bad time for the group and the CRM/cardiovascular industry. But the burning question is who will the new chairman and CEO be? The announcement yesterday ...

 
Out of joint: Japan must nurture markets for innovative technologies
23 June 2011
Japan w ants to develop its medtech industry. So how well does it support the technologies in which it already has a stake? If one was look into the field of joint navigation for an answer, they would find that the response is “Not very well”, ...
 Successor at Medtronic must choose how to ride out the bumps...   The feeling’s mutual: Corin, Stryker end US Cormet distribut...
Off-label promotion: how to avoid falling foul of the US FDA
18 February 2011
Off-label use of medical devices happens so often that it has become the standard of care for some disorders. But the FDA's rules on off-label use of devices are labyrinthine – and its edicts on off-label use versus off-label promotion can ...
German medtech innovation: Could do better
28 January 2011
The local economic signs have been improving for some months, and now the German medtech industry has received a fillip of sorts, in the shape of a just-released parliamentary report on the conditions for the growth of the industry. The policy ...

Test-New Commission current device thinking, but official mandate still awaited
14 September 2010
Amanda Maxwell

The European Commission ’s device unit has been particularly silent for the last year in anticipation of the political changes at EU level. But now it is ready and in a position to start talking again. Amanda Maxwell attended the first public ...

 
Clinica's MedTech Ventures: Issue 36
28 October 2009

I recently visited Norway with senior business reporter Joseph Harvey to uncover some of the hidden medtech gems there. These were not too hard to find, considering that the country's public healthcare system – which is strongly supportive of ...

 
 
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