In Vivo 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

Final decision for NeoPath's primary screener soon:

This article was originally published in Clinica

Executive Summary

NeoPath, the first company to receive an FDA panel approval recommendation for primary use of its automated cervical screening device, said it expected to resolve conditions laid down by the panel shortly (see Clinica No 794, p 15). Labelling conditions, which must be resolved before the company's AutoPap system can be approved, were identified in a letter to the company from the FDA. "The FDA states that it is committed to providing the company with a decision letter on its PMA as soon as possible" said the company.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT080563

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