Press Releases

MCRA Assists CorFlow in Obtaining Breakthrough Device Designation

MCRA, LLC, a leading medical device advisory firm and Clinical Research Organization (CRO

THINK Surgical and MCRA Announce 510(k) Clearance and US Launch of Revolutionary Total Knee Replacement Technology

MCRA Strengthens its Cardiovascular and Digital Health Franchise with Hiring Former FDA Assistant Director Nicole Goodsell Batista

WASHINGTON DC, November 19, 2019 /PRNewswire/ -- MCRA, LLC, is a leading medical device advisory firm and clinical research organization (CRO) that

MCRA Hires Reimbursement Leader Tonya N. Dowd, MPH, as Vice President of Reimbursement, Health Economics, & Market Access

WASHINGTON, AUG 22, 2019 /CMW/ -- MCRA, LLC a leading medical device advisory firm and Clinical Research Organization (CRO) integrating US and Int

MCRA Assists Intellirod Spine with 1st ever Spine De Novo Decision by the FDA

WASHINGTON, April 4, 2019 /PRNewswire/ -- MCRA, LLC has announced its role in the successful granting of the first De Novo for a device in

MCRA Assists with Premarket Approval of the M6-C Artificial Cervical Disc - 1st Spine PMA Approved by the FDA in More than Three Years

WASHINGTON, March 7, 2019 /PRNewswire/ -- MCRA, LLC announced today its role in the successful Premarket Approval (PMA) application decision by th

MCRA Hires FDA Interventional Cardiology Devices Branch Chief Michael John as VP of Cardiovascular Regulatory Affairs

WASHINGTON, March 5, 2019 /PRNewswire/ -- MCRA, LLC, a leading medical device consulting firm and clinical research organization (CRO) that integra

MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

The session aimed to collaboratively explore U.S. device regulations and offer high-level knowledge about the FDA review process.

MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA

WASHINGTON, Jan.

MCRA Assists SANUWAVE with Successful De Novo Decision: 3rd Wound Care De Novo Since 2010

SANUWAVE retained MCRA in January of 2015 to lead interactions and correspondence with the FDA for the dermaPACE.

MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

NEW YORK, Dec.

MCRA Leads Innovation Training with FDA as Part of its Experiential Learning Program (ELP)

The Experiential Learning Program (ELP) is a learning opportunity designed to help all levels of FDA within the Center for Devices and Radiological

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