EMEA about to open doors to Advanced Therapy product applications
The European Medicines Agency (the EMEA) is readying itself to deal with Advanced Therapy Medicinal Products as of the beginning of next year.

Monday 5 January 2009

European Commission consults on future healthcare workforce needs
In a Green paper adopted this week, the European Commission observes that there will multiple new challenges facing health systems and health employees.
Thursday 18 December 2008

EC's intent on HCAI control gets industry backing
The European Commission demonstrated the importance that it attaches to the prevention and control of healthcare-associated infections (HCAIs) by issuing a Communication and a proposal for a Council Recommendation on patient safety and the quality of health services.
Thursday 18 December 2008

US FDA updates guidance on PMA supplements
The US FDA publishes a guidance document on December 11 that advises industry on the regulatory pathway to take when companies modify class III devices that are subject to premarket approval (PMA).
Wednesday 17 December 2008

New pacemaker connector must be tested before, not after, FDA approval, scientists say
The US FDA is allowing the sale of potentially dangerous pacemaker equipment, two high-profile cardiologists allege.
Wednesday 17 December 2008

Where medtech transforms lives: a view from Canada
The Canadian industry association, MEDEC, has rallied doctors and patients together for a campaign to raise awareness about the value of medical technology in the lives of Canadian citizens. Here, campaign participant, Dr David Psutka, senior surgeon in the Total Joint Programme at Mount Sinai Hospital in Toronto, writes for Clinica about his work with prothesis technology both in Canada and globally.
Tuesday 16 December 2008

Analyst highlights top US healthcare issues in 2009
Although the industry has historically been less vulnerable to economic downturns than other industries, the disrupted economy will hit home next year, says PricewaterhouseCoopers.
Tuesday 16 December 2008

Mesothelioma: UK experts lift the lid on global "silent epidemic" research needs
High risk and inaction characterise asbestos safety and mesothelioma care policy globally. Bernard Murphy explains the irony behind a meeting held last week in Westminster Palace to push for medtech-centred R&D in this area.
Friday 12 December 2008

Portugal opens a door to passer-by AED use
Portugal is to set up a national network of automatic external defibrillators (AEDs), backed by legislation allowing non-medical, passer-by use of the device in public areas, subject to licensing arrangements. The plans, which hinge on the principle that external defibrillation is a medical activity, are set out in draft legislation, now out for public consultation.
Thursday 11 December 2008

Clinica at RSNA 2008: An interactive feature
This year's Radiological Society of North America (RSNA) conference, held in Chicago, Illinois, had a different focus to last year's, which was dominated by CT's "slice war", says Madeleine Armstrong. Companies are now insisting that the slice war is over, and are focusing on other CT technologies such as spectral imaging.
Tuesday 9 December 2008

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