Sep — 2023 MCRA Assists Ceribell with Obtaining FDA Breakthrough Device Designation, FDA Marketing Authorization, and CMS NTAP Reimbursement for ClarityPro Device Read Article
Aug — 2023 MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon MCRA is pleased to announce its role in the successful Premarket Approval (PMA) application decision by the U.S. Read Article
Jul — 2023 MCRA Expands Biocompatibility Division with Key Hire of Board-Certified Toxicologist Read Article
Jul — 2023 MCRA Announces Foundational Sponsorship of the AAOS OrthoPitch Technology Competition Read Article
May — 2023 MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System MCRA is pleased to announce its role in assisting Noctrix Health obtain marketing authorization via a De Novo Request from the U.S. Read Article
Apr — 2023 MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Porous PEEK Cervical Interbody System MCRA is pleased to announce its role in the successful 510(k) clearance decision by the U.S. Read Article
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. Read Article
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 Read Article
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. Read Article
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 Read Article
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. Read Article