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


In Brief: Angeion

This article was originally published in The Gray Sheet

Executive Summary

Angeion: Company resumes U.S. clinical implants of its Sentinel series of implantable cardioverter defibrillators immediately following FDA sign-off on Jan. 26, the firm states. The company had temporarily suspended implants of the Sentinel series, including 2000, 2010, 2011 and 2012 models, in November 1997 following five incidents in which battery voltage depleted prematurely due to a defective capacitor ("The Gray Sheet" Nov. 17, I&W-3). To correct the problem, Angeion changed its manufacturing process to incorporate a new capacitor component, and the firm has modified the monitoring schedule for patients implanted with the ICDs. Angeion filed a premarket approval application for the devices in June 1997 that is currently under review ("The Gray Sheet" June 23, In Brief)...

You may also be interested in...

What Lies Ahead: COVID-19 Vaccination Challenges

The director of adult immunizations at Johns Hopkins International Vaccine Access Center talks to Scrip about undertaking a massive COVID-19 vaccination effort in the US.

P&G: Sales Growth Strongest When Rising Tide Floats All Competitors Across All Categories

P&G’s oral care business drove 35% of total category market growth in the firm’s fiscal 2020 and exemplifies its growth strategy for all segments – grow entire categories rather than take competitors’ market share, says CFO Jon Moeller.

COVID-19 Vaccine 'Brexit Bonus' A Myth

The Pink Sheet explains the procedures underpinning the UK’s emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine.




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