MCRA

MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with Ostaguard™ Coating

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星期二, 五月 7, 2024
FDA, Safety, Food, De novo, Documentation, Spine, Support, Food and Drug Administration, MCRA, Health, Contract research organization, Pharmaceutical industry

WASHINGTON, May 7, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and healthcare advisory firm is proud to announce its role in supporting Orthobond with achieving a granted US Food and Drug Administration (FDA) De Novo for the Mariner Pedicle Screw System with Ostaguard™ coating. This De Novo grant marks the first spine device to be treated with a coating that reduces bacterial contamination in the operating room.

Key Points: 
  • This De Novo grant marks the first spine device to be treated with a coating that reduces bacterial contamination in the operating room.
  • MCRA Responsible for Regulatory Strategy and Support for FDA Submission for Orthobond's Ostaguard.
  • Orthobond engaged MCRA in March 2020 to help support their pre-submission efforts in gaining FDA feedback to their proposed performance testing suite for their Ostaguard antibacterial technology.
  • On April 5th, the FDA granted the Ostaguard antibacterial coating on the SeaSpine Mariner Pedicle Screw System for commercial use.

MCRA Supports Darmiyan with FDA Approval for BrainSee Device

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星期四, 五月 2, 2024
Alzheimer's disease, FDA, Brain, MCI, Policy, Food, Montreal Cognitive Assessment, De novo, Artificial intelligence, Digital, Science, Digital health, MCRA, MRI, Marketing, Contract research organization, Pharmaceutical industry

MCRA announces its role in the successful granting of Darmiyan's De Novo request for BrainSee by the FDA.

Key Points: 
  • MCRA announces its role in the successful granting of Darmiyan's De Novo request for BrainSee by the FDA.
  • Darmiyan retained MCRA in 2021 for its broad and deep experience in Neurology, Digital Health, and Artificial Intelligence (AI).
  • John Doucet, Vice President, Neurology Regulatory Affairs – Neuromodulation and Evolving Technologies at MCRA states, "We are proud to have worked closely with Darmiyan to achieve both Breakthrough Device Designation and marketing authorization from the FDA for BrainSee.
  • The FDA Breakthrough Device Designation for BrainSee was a critical foundation for FDA collaborations during development, review, and granting of the De Novo request.

Biodesix Announces New Master Collaborative Research Agreement with Leading US Cancer Center

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星期一, 三月 25, 2024
Science, Biotechnology, Research, Oncology, Health, Medical Devices, Health Technology, Genetics, PCR, Genomics, EVP, International, Biomarker, Cancer, Proteomics, MCRA, Bio-Rad Laboratories, MSRA, MSK

Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company with a focus in lung diseases, today announced that it has entered into a new master collaborative research agreement (MCRA) with Memorial Sloan Kettering Cancer Center (MSK) under which the teams will collaborate on a development plan for diagnostic tests aimed at improving the treatment of cancer.

Key Points: 
  • Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company with a focus in lung diseases, today announced that it has entered into a new master collaborative research agreement (MCRA) with Memorial Sloan Kettering Cancer Center (MSK) under which the teams will collaborate on a development plan for diagnostic tests aimed at improving the treatment of cancer.
  • Biodesix will utilize its array of genomics, proteomics, and data mining capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK .
  • “The expansion of our previous master sponsored research agreement (MSRA) into a master collaborative research agreement with MSK is a significant milestone for Biodesix and for biomarkers in oncology diagnostics.
  • Biodesix looks forward to co-developing and validating new test concepts under these agreements,” said Scott Hutton, CEO, Biodesix.

Tom Oxley to Keynote 2024 Bioelectronic Medicine Forum in New York City

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星期二, 三月 19, 2024
General partnership, Patient, Beckman Coulter, Skin, MCRA, Litre, Mount Sinai Health System, Movement

NEW YORK, March 19, 2024 /PRNewswire/ -- Neurotech Reports , the publisher of the Neurotech Business Report and BioElectRx Business Report newsletters, announced that the Seventh Annual Bioelectronic Medicine Forum will take place on April 5, 2024.

Key Points: 
  • NEW YORK, March 19, 2024 /PRNewswire/ -- Neurotech Reports , the publisher of the Neurotech Business Report and BioElectRx Business Report newsletters, announced that the Seventh Annual Bioelectronic Medicine Forum will take place on April 5, 2024.
  • The keynote speaker at this year's event is Tom Oxley, CEO of Synchron and an interventional neurologist at Mount Sinai Health System.
  • For more information on the 2024 Bioelectronic Medicine Forum, contact Neurotech Reports at 415 546 1259 or visit this link: http://neurotechreports.com/pages/bioelectronic-medicine-forum.html .
  • Photo caption: Tom Oxley, Ph.D., M.D., will keynote the 2024 Bioelectronic Medicine Forum on April 5, 2024 in New York City.

MCRA Announces the Hiring of FDA Statistician for Diagnostic Devices

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星期四, 二月 22, 2024
Computer, Senior, AI, Data monitoring committee, FDA, CDRH, Radiology, Regulatory affairs, Contract research organization, Patient, Biostatistics, Knowledge, Device, MCRA, Artificial intelligence, Medical device

WASHINGTON, Feb. 22, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce the hiring of FDA Mathematical Statistician for Diagnostic Devices, Chava Zibman, Ph.D., as Principal Statistician, Diagnostics at MCRA.

Key Points: 
  • WASHINGTON, Feb. 22, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce the hiring of FDA Mathematical Statistician for Diagnostic Devices, Chava Zibman, Ph.D., as Principal Statistician, Diagnostics at MCRA.
  • MCRA hires FDA Mathematical Statistician, Diagnostic Devices Chava Zibman Ph.D. as Principal Statistician, Diagnostics.
  • Dr. Zibman brings over fifteen years of statistical experience and over ten years of direct FDA experience to the position, working in the Center for Devices and Radiological Health (CDRH).
  • I am eager to help MCRA grow as the preferred consulting firm for companies seeking statistical assistance for their diagnostic devices."

MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System

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星期二, 二月 20, 2024
Engineering, Architecture, PEEK, FDA, Food, 3D, Spine, Contract research organization, Health, Fused filament fabrication, MCRA, 3D printing

MCRA aids Curiteva with 510(k) clearance from FDA for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System.

Key Points: 
  • MCRA aids Curiteva with 510(k) clearance from FDA for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System.
  • Curiteva partnered with MCRA previously on Inspire Trabecular PEEK Cervical Interbody Fusion System in February 2023, which also received FDA clearance.
  • MCRA's Spine Regulatory team engaged with Curiteva for the Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures.
  • Justin Eggleton, Vice President, Head of Musculoskeletal Regulatory Affairs at MCRA, said "MCRA is honored to have collaborated on the pioneering project of Curiteva's Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System with HAFUSE Technology and the resulting FDA clearance.

Groundbreaking Innovation in Musculoskeletal Healthcare Takes Center Stage at AAOS 2024 Annual Meeting: CytexOrtho Named OrthoPitch Technology Competition Winner

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星期三, 二月 14, 2024
Multi-monitor, SAN, Committee, Doctor of Philosophy, DBT, MD, Physician, FDA, Surgeon, Cell, Biopharmaceutical, Therapy, Joint, Health, Patient, Clinical trial, Medicine, MCRA, AAOS, American Academy, Medical device

SAN FRANCISCO, Feb. 14, 2024 /PRNewswire/ -- The American Academy of Orthopaedic Surgeons (AAOS) named CytexOrtho the winner of the inaugural OrthoPitch Technology Competition during the AAOS 2024 Annual Meeting in San Francisco.

Key Points: 
  • SAN FRANCISCO, Feb. 14, 2024 /PRNewswire/ -- The American Academy of Orthopaedic Surgeons (AAOS) named CytexOrtho the winner of the inaugural OrthoPitch Technology Competition during the AAOS 2024 Annual Meeting in San Francisco.
  • Through the competition, the AAOS, the world's largest medical association of musculoskeletal specialists, aims to fuel innovation and foster advancements with the potential to improve or transform existing standards of orthopaedic care.
  • "Being named winner of the first OrthoPitch competition validates the hard work our team at CytexOrtho has devoted to helping patients through this technology," Dr. Estes said.
  • Ultimately, CytexOrtho was named the winner, impressing both the judges and audience, which contributed to the outcome via a live online vote.

MCRA Announces European Expansion

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星期三, 一月 10, 2024
Service, Patient, Notified body, Quality assurance, GDPR, Knowledge, Risk, MCRA, Medtech, Regulatory affairs, UDI, Contract research organization, Pharmaceutical industry

WASHINGTON, Jan. 10, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its expansion in Europe with three new offices in London, United Kingdom, Winterthur, Switzerland, and Eschborn, Germany.

Key Points: 
  • New Services and Offices in United Kingdom, Switzerland, and Germany
    In addition to these new offices, MCRA has also expanded its service offerings in Europe to accommodate growing client needs.
  • MCRA Europe now offers GDPR compliance, representative services for clinical studies and Unique Device Identifier (UDI) services in addition to its core services of Regulatory Affairs, Clinical Research and Quality Assurance.
  • Abigail Allen, Vice President, Clinical Affairs states, "Our European presence further supports our global CRO by facilitating access to European patients and utilizing our country specific knowledge and expertise to streamline approvals and trial management.
  • Anthony Viscogliosi, CEO of MCRA, states "Europe is the second largest medical device market in the world.

MCRA Announces the Hiring of New Director of Patient Access Program Operations

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星期三, 十二月 13, 2023
JD, Depression, Patient, Insurance, Medtech, Obesity, Contract research organization, Health, Environment, Market access, Knowledge, Asthma, Bariatric surgery, Government, MCRA, Glaucoma, Pharmaceutical industry, Nursing

WASHINGTON, Dec. 13, 2023 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce the hiring of patient access veteran, Walter Lindstrom, as the new Director of Patient Access Program Operations to its Reimbursement, Healthcare Economics, and Market Access (RHEMA) Team.

Key Points: 
  • WASHINGTON, Dec. 13, 2023 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce the hiring of patient access veteran, Walter Lindstrom, as the new Director of Patient Access Program Operations to its Reimbursement, Healthcare Economics, and Market Access (RHEMA) Team.
  • MCRA hires patient access veteran Walter Lindstrom as  new Director of Patient Access Program Operations.
  • Having Walter join the MCRA reimbursement team will allow us to enhance our patient access program and truly enhance the value we provide to our clients."
  • Anthony Viscogliosi, CEO of MCRA, states "Investing in patient access programs highlights our commitment to better serving patients around the world.

MCRA Announces Launch of Integrated AI & Imaging Center

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星期一, 十一月 27, 2023
Data management, Quality, Regulation, Doctor of Philosophy, MCRA, FDA, Medical device, Data collection, Contract research organization, Trial of the century, AI, Integration, Food, Digital health, Radiology

WASHINGTON, Nov. 27, 2023 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce the launch of its AI & Imaging Center, the first and only integrated solution, led by former FDA imaging experts covering the entire Medical Device product lifecycle.

Key Points: 
  • MCRA's AI & Imaging Center was developed to better meet the emerging and complex needs of imaging technologies.
  • Led by former FDA regulatory and imaging operations experts, the Integrated AI & Imaging Center provides critical services to medical device clients developing AI/ML enabled devices and novel imaging technologies.
  • As a fully integrated solution, MCRA AI & Imaging Center utilizes well-established zero print, state of the art imaging analysis and data management software with 24/7 support for clients and network specialists.
  • Anthony Viscogliosi, CEO of MCRA says "The MCRA AI & Imaging Center truly integrates our deep regulatory experience with clinical study execution, technology and performance testing.