Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

U-Systems’ somo-v Breast Ultrasound Device Heads To Panel

This article was originally published in The Gray Sheet

Executive Summary

Radiological devices panel will review U-Systems’ PMA for breast cancer screening on April 11. The next day, the panel will discuss potential reclassification of pre-amendment breast transilluminator devices and the classification of blood irradiators.

You may also be interested in...



News In Brief

GE Healthcare files first component of a modular PMA submission for 3-D breast tomosynthesis. Biocartis raises $100 million. More news briefs.

New PMA Requirement Proposed For Apparently Nonexistent Devices

CDRH is proposing to require PMAs for four categories of devices for the first time, but it is not likely to hear much resistance from industry

Second EU MDR Notified Body Designated In France

Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT031025

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