Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Ortho Companies Emphasize Software For Patient-Matched Instrumentation Guidance

This article was originally published in The Gray Sheet

Executive Summary

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...



US FDA Works To Finalize 3D Printing Guidance; Industry Asks For More

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.

Large Joint Replacement Market: Set For A Rebound?

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.

Two Companies, One Owner; US FDA Sends Warning Letters To Same Address For Similar Issues

Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

MT033799

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel