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

In Brief: Conceptus

This article was originally published in The Gray Sheet

Executive Summary

Conceptus: Receives FDA letter stating falloposcopes used to evaluate proximal tubal occlusion in the fallopian tube will be reviewed via the 510(k) route. "Clinical data will be required to support a 510(k) application for falloposcopy devices for this indication," the company says, and "data in the 510(k) application should support substantial equivalence of the falloposcope to selective salpingography catheters and hysteroscopes." Conceptus, which submitted a 510(k) with clinical data in June for its Fallopian Tube Catheterization with Microendoscopy (FTCM) system ("The Gray Sheet" July 15, In Brief), petitioned FDA in October 1995 to downclassify falloposcopes to Class II...

You may also be interested in...



QUOTED. 27 November 2020. Agam Sharda.

The first trial of the new Flash ultra-high dose radiation therapy with Varian Medical Systems’ ProBeam particle accelerator has begun. Agum Sharda, Varian’s senior director of Flash, says the technology could be a major advance for cancer patients.

Real World Data Failed To Impress Kaftrio’s European Reviewers

The European public assessment report for Kaftrio shows that EU regulators had concerns about whether Vertex’s triple drug combination for cystic fibrosis represented a new treatment paradigm.

Swissmedic Clears Up Confusion Over Validity Of GMP Certificates

Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.

UsernamePublicRestriction

Register

LL018264

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