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
UsernamePublicRestriction

Arrhythmia monitors should be Class II devices subject to special controls -- Zymed petition.

This article was originally published in The Gray Sheet

Executive Summary

ARRHYTHMIA MONITOR DOWNCLASSIFICATION TO CLASS II WITH SPECIAL CONTROLS is called for by Zymed Medical Instrumentation in a July 30 petition to FDA. The Camarillo, California-based company bases its argument on the fact that the "algorithm core" used in its Central Station telemetry arrhythmia monitoring system is identical to that employed in other Zymed arrhythmia detection systems used to retrospectively review electrocardiograph data, which are regulated as Class II devices.

You may also be interested in...



Hikma Adds Sesen’s Vicineum To MENA Brands

Hikma and Sesen Bio have struck a deal that will see Hikma distribute the Vicineum brand in the MENA region.

Netherlands’ Norgine Sets Up OTC Business And Targets Acquisitions

By establishing a dedicated consumer healthcare subsidiary, Norgine is hoping it can grow its $200m-plus Movicol laxative brand and take advantage of M&A opportunities in the OTC market.

AAM Urges Supreme Court To Uphold Inter Partes Review

The AAM has insisted that the US Supreme Court should uphold the inter partes review framework, in an amicus brief filed as part of litigation that potentially threatens hundreds of IPR decisions.

UsernamePublicRestriction

Register

OM013133

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