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

MiniMed To File Home-Use Continuous Glucose Monitor PMA In Early 2000

This article was originally published in The Gray Sheet

Executive Summary

MiniMed is developing a follow-on version of its continuous glucose monitoring system (CGMS) that will be sold directly to patients, allowing them to monitor their own glucose levels, the firm said following FDA's June 16 approval of a non-consumer configuration as an adjunct to finger-stick blood glucose testing.

You may also be interested in...



Medtronic MiniMed Consumer CGMS PMA Supplement To Be Refiled In Dec.

Medtronic MiniMed's proposed labeling for the consumer version of its continuous glucose monitoring system (CGMS) "will not be as aggressive" as the firm originally planned, President Terry Gregg said Sept. 25 at an institutional investor conference in Minneapolis.

Medtronic MiniMed Consumer CGMS PMA Supplement To Be Refiled In Dec.

Medtronic MiniMed's proposed labeling for the consumer version of its continuous glucose monitoring system (CGMS) "will not be as aggressive" as the firm originally planned, President Terry Gregg said Sept. 25 at an institutional investor conference in Minneapolis.

MiniMed Faces FDA Panel For Consumer Glucose Sensor; Dampens Outlook

MiniMed's home-use continuous glucose monitoring system (CGMS) could be reviewed by FDA's Clinical Chemistry and Clinical Toxicology Panel as early as May 9, the company says.

Related Content

UsernamePublicRestriction

Register

MT011953

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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