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

UsernamePublicRestriction
UsernamePublicRestriction

BAMF Spine approval delayed; US launch slated for next year

This article was originally published in Clinica

Executive Summary

The BAMF (balloon-assisted management of spine fractures) Spine product, developed by AOI Medical to treat compression fractures of the spine caused by osteoporosis, cancer or trauma, may not reach market until the end of next year. The US FDA has extended the consultation period for the device's 510(k) submission for a further 90 days, to consider the necessity of a confirmatory study. Orlando, Florida-based AOI expects to meet with the FDA again in late October, but acknowledges that US launch of BAMF Spine will occur either in the first quarter of 2008 if no clinical trials are required, or the second half of 2008 if trials are required.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT049921

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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