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

UsernamePublicRestriction

Heater-Cooler Systems Face FDA Scrutiny

This article was originally published in The Gray Sheet

Executive Summary

The agency has issued a safety alert on the risk of bacterial infections linked to the use of LivaNova/Sorin's heater-cooler units during open-chest surgery, and held an advisory panel meeting last week to discuss strategies to better ensure safety of these and similar devices.

You may also be interested in...



‘Dangling’ Cancer Indications In US: New Year Brings New Withdrawals Of Accelerated Approvals

Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.

Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims

US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.

Merger Enforcement: FTC And Justice Department Casting Wide Net In Considering Changes

Agencies seek public comment on how they can modernize merger guidelines to enforce antitrust laws. List of questions, including what types of evidence show that a merger could reduce competition, indicate pharma and other mergers will face greater scrutiny.

Topics

Related Companies

UsernamePublicRestriction

Register

MT034834

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