Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


Piper Jaffray Healthcare Conference In Brief

This article was originally published in The Gray Sheet

Executive Summary

J&J/DePuy ASR hip: Investigational device exemption filing for the Articular Surface Replacement less-invasive hip system will be submitted to FDA this year, leading to a U.S. launch in 2007, J&J Worldwide Chairman-Medical Devices & Diagnostics Michael Dormer reports at a Jan. 27 session of the Piper Jaffray Healthcare Conference in New York. A European debut is slated for this quarter. Targeting a $500 mil. market, the device "provides excellent function with less damage to the natural bone structure" and "permits total hip replacement in later years should the need ever arise," the exec explains. J&J also is readying the Proxima conservative hip replacement system, preparing to begin European trials by Q2 with hopes for a 510(k) submission by Q1 2005. Proxima is designed to support minimally-invasive surgical techniques. A ceramic-on-ceramic hip bearing already available outside the U.S. is on track for U.S. approval in the second half of 2004...

You may also be interested in...

S&N Preps For Potential Ceramic Hip Launch At March AAOS Meeting

Smith & Nephew expects PMA approval of a ceramic-on-ceramic hip by the second quarter of 2004, according to Orthopedics Division President David Illingworth

Abbott’s Lake County Plant Gets FDA Nod; Prism Squares Up For U.S. Debut

Abbott Labs will begin U.S. commercialization of its Prism, Architect and AxSYM full diagnostic assay menus over the next 12 months, following FDA's decision to end a four-year prohibition of product sales

Device Week, 4 December 2020 – MedWatch Question About Third-Party Servicers Slides Under Industry's Radar

On this week’s podcast: A change made by the US FDA to its MedWatch program that asks adverse event reporters whether a third party serviced a malfunctioning medical device went unnoticed by many in industry for nearly a year. We explain why, and tell how the servicer question will be helpful for manufacturers and the agency.




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