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

FDA panel recommends approval for computer-assisted mammography screening device

This article was originally published in Clinica

Executive Summary

An FDA advisory committee has unanimously recommended that the US agency approve, with labelling conditions, a computer-assisted device which picks out suspect areas on mammograms. The M1000 ImageChecker System, made by R2 Technology, will be used as an aid to radiologists while screening mammograms.

You may also be interested in...



New EU Filings

Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

BMS Has A Strong Pipeline, But Access Challenges Remain

Bristol Myers Squibb’s head of major markets, Monica Shaw, wants to improve patients’ access to lifesaving therapies. And the group has several new products ready to roll.

Novartis Nominates Ex-BMS Chief As It Pursues US Growth Strategy

The Swiss pharma company is looking to tap into the experience of ex-BMS leader Giovanni Caforio to help further it US-first commercial strategy.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT081444

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