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

Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Medtronic epilepsy device gets new panel date: FDA's neurological devices advisory panel will review a pre-market approval application for Medtronic's deep brain stimulation implant for epilepsy on March 12, after a November 2009 panel review of the device was postponed. The device is intended as an adjunct to drug therapy for reducing the frequency of seizures in patients with drug-refractory epilepsy with partial-onset seizures. Medtronic says it anticipates approval by this summer (1"The Gray Sheet" Nov. 30, 2009). The firm has marketed its Activa DBS therapy for Parkinson's and essential tremor for more than a decade, and is also pursuing a depression indication

You may also be interested in...



Medtronic Aims For Epilepsy DBS Implant Approval By Summer

Medtronic is aiming for PMA approval of its deep brain stimulation implant for epilepsy by next summer, despite a recent delay in a scheduled FDA advisory panel review of the device

Separation Key To Posting Studies Linking Dietary Ingredients To Preventing Or Treating Disease

DSHEA’s Scientific Literature Exemption is attracting attention for offering online studies showing nutrients’ benefits on diseases including COVID-19, though the method isn’t free of risks, suggests CRN executive Megan Olsen.

Hanmi And LG Chem Highlight Vaccine Prowess, Novel R&D At JPM

Hanmi showcases at JPM its contract production capabilities for COVID-19 vaccines as South Korea prepares to bring in candidates from several global developers, while LG Chem highlights progress across multiple pipeline projects.

Topics

UsernamePublicRestriction

Register

LL016481

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