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

FDA Inks Class II Designation For Embryo Viability Tests

This article was originally published in The Gray Sheet

Executive Summary

The agency set a class II with special controls designation for assisted reproduction embryo image assessment systems in a Feb. 26 final order, following the de novo decision for Auxogyn’s Eeva system last summer.

You may also be interested in...



Testing For Toxicity In Fertility Treatment Technologies

US regulators are proposing makers of fertility assistant devices first test their products on mice embryos in the lab to better understand any potential toxicity risk to human embryos and the viability of the fetus.

EU Extends Provisions For Ensuring Post-Brexit Flow Of Medicines

Proposals for averting medicines supply disruptions caused by Brexit in Northern Ireland and three EU markets are about to be discussed by EU legislators.

Teva Agrees To $420m Securities Settlement For Alleged Price Fixing

Denying any wrongdoing or admission of liability, Teva has agreed to a proposed settlement of $420m with a class of investors following allegations that the firm had concealed the true nature of its increase in profits, which artificially inflated the price of Teva’s securities.

Related Companies

UsernamePublicRestriction

Register

MT034544

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