Ortho Companies Emphasize Software For Patient-Matched Instrumentation Guidance
This article was originally published in The Gray Sheet
Orthopedic device companies say FDA should provide guidance on how software used to design and implant patient-matched instrumentation could be regulated. They note that while physician experience and training is the key factor for surgeries using such devices, software is critical to how patient data is collected, evaluated and shared among surgeons and pre-operative personnel.
You may also be interested in...
A top FDA device official says the agency is hoping to finalize an additive manufacturing guidance this year. Industry is particularly interested in seeing the leap-frog guidance made final, but would also like to see more clarification and a separate guidance to address the topic of patient-specific manufacturing.
Beaten down by the great recession, the large joint arthroplasty market appears to be on the cusp of a turnaround, with several big players reporting encouraging Q4 and full-year 2012 results. A full recovery in this space is likely to take some time, but technology advances could help jumpstart the process, and there may be some interesting dynamics ahead in the patient-specific implant and robotic ortho device arenas.
At last! After an intense year of lobbying by the medtech sector decision-makers have agreed that compliance deadlines must be delayed under the EU’s Medical Device Regulation.