mcra
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Regulatory
MCRA CRO Assists Simplify Medical, Inc. on the Fastest Spine PMA Ever Approved by the FDA
WASHINGTON, Oct. 1, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory firm and Clinical Research Organization (CRO) integrating U.S.…
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Financial
MCRA Strengthens its Reimbursement, Health Economics, and Market Access Division with the Hiring of Tess Wong, MS
WASHINGTON, Jan. 16, 2020 /PRNewswire/ — MCRA, LLC, is a leading clinical research organization (CRO) and advisory firm specializing in medical devices and…
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Recon
THINK Surgical and MCRA Announce 510(k) Clearance and US Launch of Revolutionary Total Knee Replacement Technology
WASHINGTON, Nov. 21, 2019 /PRNewswire/ — MCRA, LLC (www.mcra.com) is pleased to announce that its client THINK Surgical, Inc. has obtained clearance…
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Biologics
Ortho Regenerative Technologies selects US based specialized CRO, MCRA LLC, for its upcoming phase I/II rotator cuff human trial
MONTREAL, Sept. 12, 2019 /CNW/ – Ortho Regenerative Technologies Inc. (CSE: ORTH) (“Ortho RTI” or the “Company“), an emerging Orthobiologics company, announced today…
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Financial
MCRA Hires Reimbursement Leader Tonya N. Dowd, MPH, as Vice President of Reimbursement, Health Economics, and Market Access
WASHINGTON, August 22, 2019 /PRNewswire/ — MCRA, LLC (www.mcra.com), a leading medical device advisory firm and Clinical Research Organization (CRO)…
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Regulatory
Intellirod Spine Receives First-Ever Spine FDA De Novo Approval
April 01, 2019 AKRON, Ohio–(BUSINESS WIRE)–Intellirod Spine, the spinal sensor technology company developing wearable, disposable and implantable wireless sensors for…
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Regulatory
MCRA Assists with Premarket Approval of the M6-C Artificial Cervical Disc
WASHINGTON, March 7, 2019 /PRNewswire/ — MCRA, LLC announced today its role in the successful Premarket Approval (PMA) application decision by the U.S.…
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Hospitals
MCRA Hires Bonnie Clothier, PhD, RN, Associate Director, Payor Relations, to Further Expand Reimbursement Payor Relations Service Division
WASHINGTON, July 19, 2018 /PRNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the…
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Hospitals
MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA
WASHINGTON, April 24, 2018 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the…
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Hospitals
MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA
WASHINGTON, Jan. 23, 2018 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has announced its role in the successful granting of the first…
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Hospitals
MCRA Assists SANUWAVE with Successful De Novo Decision: 3rd Wound Care De Novo Since 2010
WASHINGTON, Jan. 10, 2018 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has announced its role in the successful de novo clearance by the U.S.…
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Hospitals
Sanuwave Receives FDA De Novo Decision to Immediately Market the Dermapace System for the Treatment of Diabetic Foot Ulcers in the U.S.
SUWANEE, GA, Jan. 02, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) has announced that the U.S. Food and Drug Administration…
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Hospitals
MCRA Releases New White Paper Analyzing the Industry Impact of the Federal Budget Request on FDA
WASHINGTON, July 26, 2017 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization to the medical…
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Hospitals
MCRA Advises Orthopedic Industry To Adopt Integrated Value Creation Strategy
NEW YORK, July 11, 2017 /PRNewswire-USNewswire/ — In an address given in Paris, France to delegates attending the 13th annual IMPLANTS conference on orthopedic…
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Hospitals
MCRA Assists Cartiva, Inc. with Obtaining FDA PMA Approval for the Company’s Synthetic Cartilage Implant (SCI)
WASHINGTON, July 20, 2016 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful Premarket Approval (PMA) application…
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