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


Microsulis MEA System Labeling Changes Gain OB-GYN Panel’s Support

This article was originally published in The Gray Sheet

Executive Summary

Users of the Microsulis MEA microwave endometrial ablation system should be trained by experienced physicians, FDA's Obstetrics & Gynecology Devices Panel recommended June 10

You may also be interested in...

Microsulis launches MEA system

U.S. commercial use of minimally invasive microwave endometrial ablation device for uterine lining ablation commences Oct. 6 following PMA approval Sept. 23. Microsulis is training physicians on the device, as was recommended in a June FDA approval condition (1"The Gray Sheet" June 16, 2003, p. 28)...

After EUA, US Will Ship Only Half Of Doses For Pfizer, Moderna COVID-19 Vaccines

Operation Warp Speed will hold back initial shipments to ensure two-dose regimens can be completed; 15 December is ‘chalk’ target date for emergency authorization of Pfizer vaccine, OWS’ Gustave Perna says, calling it only a projection that does not impinge on FDA authority. Sending only half shipments also eases burden on cold shortage capacity at state and local level, he says.




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