3DM Gesture

3DM is not just 3D Printed Models. The Gesture product is already being used in surgeries in Toronto and US & Canadian hospitals
http://3dmedical.com.au/wp-content/uploads/2014/11/ValueProp_BioMed1.pdf
"...Assembled in accordance to Good Manufacturing Practices (GMP) and is registered as an FDA Class 1 device..."

"...Surgeons rely on an array of MRI and CT scans during a procedure.
But they can't navigate those images because the keyboard
and mouse that control them aren't sterile.
...
surgeon is forced to scrub out, consult the imaging, and then leave the operating room to scrub back in. This process can take up to 10 minutes: Precious time when a patient is anesthetized, and expensive at an OR time cost of $62 per minute
...
Used in surgeries in Toronto for over 3 years and currently installed at a number of U.S. and Canadian hospitals
..."


"What does it mean for FDA to "classify" a medical device?"
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm
"...Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls..."