Press Releases

Feb — 2023

MCRA Assists TriReme Medical with Obtaining FDA Premarket Approval of Cardiovascular Balloon Catheter

MCRA is pleased to announce its role in the successful Premarket Approval (PMA) application decision by the U.S.

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Feb — 2023

MCRA Assists Medtrade with CELOX™ PPH CE Mark, Advancing Strategy and Time to Market

MCRA is pleased to announce its work with Medtrade on obtaining the CE Mark for its CELOX

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Dec — 2022

MCRA Announces New Vice President of Reimbursement, Healthcare Economics, and Market Access

MCRA is pleased to announce the hiring of Michael Anselmo as Vice President, Reimbursement, Health Economics, and Market Access.

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Nov — 2022

MCRA Expands into Anesthesia and Critical Care Therapy Specializations, Hires FDA Assistant Director

MCRA is pleased to announce the addition of anesthesia and critical care as a new therapy specialization, led by former FDA Assistant Director Todd

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Oct — 2022

MCRA Expands European IVD Division, Hires Former BSI Global Head of IVD

MCRA is pleased to announce the expansion of its European Regulatory Affairs division with the hiring of Dr.

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Oct — 2022

MCRA Expands Biostatistics Division with Key Hire of Former FDA Biostatistician

MCRA is pleased to announce the formation and expansion of its biostatistical division, led by former FDA biostatistician Alvin Cutler Van Orden.

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Aug — 2022

MCRA Expands Recently Formed Biocompatibility Division with 2 Key Hires from FDA and Industry

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Jul — 2022

MCRA Assists NeuroMetrix with Obtaining FDA Breakthrough Device Designation and Marketing Authorization in One Year

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Jun — 2022

MCRA and Clients Achieve Significant Milestone - Over 60 Breakthrough Device Designations Granted by FDA

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Jun — 2022

MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA

MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S.

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Jun — 2022

MCRA Assists Net Health in Receiving Breakthrough Device Status

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Mar — 2022

MCRA Acquires Vorpal Technologies K.K. to Further Expand its Global Advisory Services in Japan

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Expand Your Healthcare Distribution With MCRA Global Access

A unique integrated perspective for creating the optimal product pathway

Deep Therapy Experience

Expand Your Healthcare Distribution With MCRA Global Access

Press Releases

MCRA Assists TriReme Medical with Obtaining FDA Premarket Approval of Cardiovascular Balloon Catheter

MCRA Assists Medtrade with CELOX™ PPH CE Mark, Advancing Strategy and Time to Market

MCRA Announces New Vice President of Reimbursement, Healthcare Economics, and Market Access

MCRA Expands into Anesthesia and Critical Care Therapy Specializations, Hires FDA Assistant Director

MCRA Expands European IVD Division, Hires Former BSI Global Head of IVD

MCRA Expands Biostatistics Division with Key Hire of Former FDA Biostatistician

MCRA Expands Recently Formed Biocompatibility Division with 2 Key Hires from FDA and Industry

MCRA Assists NeuroMetrix with Obtaining FDA Breakthrough Device Designation and Marketing Authorization in One Year

MCRA and Clients Achieve Significant Milestone - Over 60 Breakthrough Device Designations Granted by FDA

MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA

MCRA Assists Net Health in Receiving Breakthrough Device Status

MCRA Acquires Vorpal Technologies K.K. to Further Expand its Global Advisory Services in Japan