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

Potential Pump Malfunction Results In Class I Recall For LifeSPARC Circulatory System

Executive Summary

The US FDA has labelled a recall of several hundred components of the LifeSPARC circulatory support system from LivaNova as class I, the agency’s most serious recall designation.

You may also be interested in...



News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants

Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.

LivaNova To Buy TandemLife For Up to $250m, Adding Complementary Cardiac Surgery

London-based cardiac surgery and neuroscience group LivaNova PLC is buying privately held Pittsburgh-based TandemLife in a deal worth up to $250m. TandemLife develops advanced cardiopulmonary temporary support systems that are complementary to LivaNova's cardiac surgery segments.

News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR

This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145887

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