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

OUS Approvals Analysis: November Product Go-Aheads Headlined by LimFlow, Abbott, Creavo

Executive Summary

The number of medical device approvals reported outside the US rebounded in November after a very slow October. There were 14 CE marks, three approvals in Japan, and three in Canada last month, covering nine different product categories.

You may also be interested in...



To Alinity And Beyond: Abbott Dx Launches Into Its Next Phase

Abbott Laboratories' diagnostic business is rolling out its new line of Alinity systems across its core lab, point-of-care, and molecular markets. Executive VP Brian Blaser says the systems are the realization of an ongoing customer-centric shift by the business, and the firm highlights a turnaround for a diagnostics unit that, only a decade ago, Abbott was trying to wash its hands of.

Biosurfit Lands CE Mark For New Three-In-One POC HbA1c Test

IVD-maker biosurfit is seeking more distribution partners to roll out its new three-in-one POC HbA1c blood test across Europe. The IVD company secured CE-marking for the test to assist doctors diagnose and monitor diabetes.

TCT 2016: Three-Year ABSORB II Data Fail To Show The Hoped-For Long-Term Benefit Of Bioresorbable Stent

The data, presented Oct. 30 at the TCT Conference in Washington, DC, also showed higher rates of device-related adverse events including myocardial infarction with Abbott’s Absorb bioresorbable stent than a metallic drug-eluting stent, but the study was not powered to show differences in clinical endpoints, so this adverse safety signal must be evaluated in future clinical trials.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT104201

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