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

Exagen Files First Of Six Planned 510(k)s For Genomic Test Kits

This article was originally published in The Gray Sheet

Executive Summary

Exagen Diagnostics recently filed the first of six planned 510(k) applications for test kits developed using its novel Coperna computational platform, kicking off a major push into the nascent genomic test kit market

You may also be interested in...



People In Brief

Coyle joins Medtronic: Ten-year St. Jude Medical veteran Michael J. Coyle has been hired to lead Medtronic's cardiology businesses as an executive VP and group president reporting to CEO Bill Hawkins, the firm announced Dec. 2. Coyle is filling a post created by Medtronic in August, when the firm restructured its businesses into two overarching groups: one, led by Chris O'Connell, includes the Spinal and Biologics, Neurostimulation, Diabetes and Surgical Technologies units, and the other, now led by Coyle, includes Cardiac Rhythm Disease Management, Cardiovascular and Physio-Control (1"The Gray Sheet" Sept. 7, 2008). Coyle helmed St. Jude's cardiac rhythm management business from 2001 to 2007 and its Daig catheter division from 1997 to 2001. For the past two years he has worked as an independent consultant

People In Brief

Coyle joins Medtronic: Ten-year St. Jude Medical veteran Michael J. Coyle has been hired to lead Medtronic's cardiology businesses as an executive VP and group president reporting to CEO Bill Hawkins, the firm announced Dec. 2. Coyle is filling a post created by Medtronic in August, when the firm restructured its businesses into two overarching groups: one, led by Chris O'Connell, includes the Spinal and Biologics, Neurostimulation, Diabetes and Surgical Technologies units, and the other, now led by Coyle, includes Cardiac Rhythm Disease Management, Cardiovascular and Physio-Control (1"The Gray Sheet" Sept. 7, 2008). Coyle helmed St. Jude's cardiac rhythm management business from 2001 to 2007 and its Daig catheter division from 1997 to 2001. For the past two years he has worked as an independent consultant

FDA Clears First-Of-A-Kind Breast Cancer Recurrence Test

Dutch firm Agendia's MammaPrint test for predicting breast cancer recurrence set regulatory precedent Feb. 6 when it received 510(k) clearance

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT024684

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