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

Global Device Approvals, Weekly Snapshot: July 2-8, 2018

Executive Summary

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

You may also be interested in...



FDA Sets PMA Standard For AEDs, Giving Marketed Devices Time To Comply

FDA issued a final order on Jan. 28 requiring manufacturers of automated external defibrillators to submit premarket approval applications to market their products. This will immediately apply to new AEDs, but manufacturers of devices already on the market have 18 months to submit PMAs for those devices as long as they notify the agency by April 29.

Boston Scientific Plans New Facility In Georgia

The company will invest $62.5m for a new manufacturing and supply chain facility in Johns Creek, GA – about 30 miles northeast of Atlanta in Fulton County, according to Georgia Governor Brian Kemp.

Minute Insight: Acutus Adds Another Device To The Left-Heart Business It Sold To Medtronic

The company announced the US launch of the AcQCross Qx transseptal dilator/needle. It is specifically designed to help deploy Boston Scientific’s Watchman left-atrial appendage closure device, but it is part of the left-heart access device portfolio that Acutus recently sold to Medtronic.

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

MT122942

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