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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

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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

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