A new imaging system developed by Eykona Technologies, a medical imaging spin-out from the University of Oxford in the United Kingdom, produces 3-D colour images. A video on DeviceTalk describes the development of the system.
Handheld 3-D Imaging System for Medical Applications Opens Up New Possibilities (DeviceTalk)
The heated debate on the potential establishment of a PMA system for medical devices in Europe continues. But Europe already has an approval system for high-risk devices, stresses John Brennan, Director Regulatory and Technical Affairs Eucomed, in this blog post.
Why PMA is a step backwards in the approval approach for medical technology (Eucomed blog)
US FDA issued a final rule on the PMA process for implantable pacemakers and programmers.
FDA formalizes PMA requirement for all implantable pacemakers, programmers (MassDevice)
An article on OrthoTec discussed how hurdles such as legal liability and a changing regulatory environment could pave the way for innovations.
With Challenges Come Opportunities. Now Get to Work! (OrthoTec)
Frost & Sullivan evaluated some of the strengths and weaknesses in the medical device industry.
Change is in the Air: A Medtech Industry SWOT Analysis (Medtech Pulse)