The first HTML5 radiology viewer approved by the FDA

http://www.imedicalapps.com/2011/12/review-vue-motion-medical-image-viewer/

by veb • 15 years ago

32 3 15 years ago

Here's the clearance: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn....

As far as I understand, there is a distinction between "cleared" (for sale, as this has been) and "approved" (as in a new type of device). The bar for clearance is much lower, as a company must only demonstrate "Substantial Equivalence" to existing, approved devices, and compliance with a quality control scheme. It's kind of interesting to read the SE backreferences for some viewers - they go back to computerized viewers in the 80s or even 70s. (Certain vendors seem willfully careless with the term "approved" and far too ambitious with the SE chain they cite...)

togasystems• 15 years ago

I wonder what the impact of this will be since most radiology images are processed by a radiologist with the notes sent to the ordering doctors. Will doctor's be more inclined to view these?

rdl• 15 years ago

I was stuck supporting an activex based desktop viewer for a couple years. I kept suggesting an html5 solution, since everyone wanted iPad for non diagnostic review, and that maintaining activex controls in a locked down DOD environment is a huge pain, but people kept saying it couldnt be done.

This is great news -- I hope this makes teleradiology more widespread.

The first HTML5 radiology viewer approved by the FDA

Related Stories