News & Publications

Press Releases

MCRA Announces Launch of Integrated AI & Imaging Center

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Nov — 2023

Press Releases

MCRA Announces the Hiring of Former FDA Leadership to Advance its Regenerative Medicine Expertise

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Nov — 2023

Press Releases

MCRA Announces Hassan F. Abdallah as New Head of Healthcare Compliance

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Nov — 2023

Press Releases

MCRA Assists Attune Medical on FDA De Novo Marketing Authorization for ensoETM™ Esophageal Thermal Regulating Device

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Oct — 2023

Webinars

FDA Cybersecurity and Software Policy Updates: Navigating the New FDA Guidance Documents for MedTech Webinar

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Sep — 2023

Press Releases

MCRA Assists Ceribell with Obtaining FDA Breakthrough Device Designation, FDA Marketing Authorization, and CMS NTAP Reimbursement for ClarityPro Device

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Sep — 2023

News

Update to FDA Guidance Use of International Standard ISO 10993-1 and Biocompatibility of Devices in Contact with Intact Skin

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Sep — 2023

Press Releases

MCRA Assists Procept BioRobotics Establish Reimbursement Listing in Japan

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Sep — 2023

Press Releases

MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon

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Aug — 2023

Press Releases

MCRA Expands Biocompatibility Division with Key Hire of Board-Certified Toxicologist

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Jul — 2023

Publications

Challenges within the European MedTech Market: How MCRA’s Experts Stand Out

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Jul — 2023

Press Releases

MCRA Announces Foundational Sponsorship of the AAOS OrthoPitch Technology Competition

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Jul — 2023

Publications

UKCA and CE Transitions for IVD Medical Devices: Planning is Key

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Jul — 2023

Webinars

Navigating the Road to Successful Market Access: Health Economic Strategies for Medtech Innovators

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May — 2023

Press Releases

MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System

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May — 2023

Press Releases

MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Porous PEEK Cervical Interbody System

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Apr — 2023

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News & Publications

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MCRA Announces Launch of Integrated AI & Imaging Center

MCRA Announces the Hiring of Former FDA Leadership to Advance its Regenerative Medicine Expertise

MCRA Announces Hassan F. Abdallah as New Head of Healthcare Compliance

MCRA Assists Attune Medical on FDA De Novo Marketing Authorization for ensoETM™ Esophageal Thermal Regulating Device

FDA Cybersecurity and Software Policy Updates: Navigating the New FDA Guidance Documents for MedTech Webinar

MCRA Assists Ceribell with Obtaining FDA Breakthrough Device Designation, FDA Marketing Authorization, and CMS NTAP Reimbursement for ClarityPro Device

Update to FDA Guidance Use of International Standard ISO 10993-1 and Biocompatibility of Devices in Contact with Intact Skin

MCRA Assists Procept BioRobotics Establish Reimbursement Listing in Japan

MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon

MCRA Expands Biocompatibility Division with Key Hire of Board-Certified Toxicologist

Challenges within the European MedTech Market: How MCRA’s Experts Stand Out

MCRA Announces Foundational Sponsorship of the AAOS OrthoPitch Technology Competition

UKCA and CE Transitions for IVD Medical Devices: Planning is Key

Navigating the Road to Successful Market Access: Health Economic Strategies for Medtech Innovators

MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System

MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Porous PEEK Cervical Interbody System