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IHC Research

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Medical Devices & Imaging

Medical Devices & Imaging

The IHC staff has supported major IDE, PMA and 510K programs for numerous medical devices.

169264929-imagingWe have also conducted numerous trials utilizing medical imaging and diagnostic/screening technology in support of safety and efficacy claims.

International HealthCare (IHC) has managed the entire clinical program of several cardiovascular medical devices from direct stenting and drug-eluting stents, spine stabilizing devices, to the development of a vascular device to treat varicose veins.  Medical device trials require an added level of specialized service and regulatory knowledge to be executed successfully.  IHC understands the regulations required for PMA and 510K submissions, and therefore can assist your project team in designing the scope and breadth of those clinicals necessary to succeed.

The following is a brief overview of IHC’s experience:

Cardiovascular/Respiratory

  • Stenting: Safety, Efficacy and Registry trials – both regular and drug eluding products
  • ACT diagnostic tool comparative claims
  • Heparin-Induced-Thrombocytopenia (HIT) Antibody Test efficacy
  • COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support

Imaging

  • Mammography
  • Radiography
  • Endoscopy/Colonoscopy

Orthopaedics

  • Spine – Lumbar Stenosis
  • Sports Medicine – Cartilage Repair
  • Periprostehetic Joint Infections
  • IDE Pivotal Trials
  • Feasibility/Pilot Assessments

Endovascular

  • Stenting: Peripheral, Renal Salvage and Registry, Doppler & Duplex Imaging
  • Abdominal Aortic Aneurysm: Safety/Efficacy trial
  • Varicose Veins: Safety, Efficacy, and Imaging (Duplex Ultrasound Retrograde Blood Flow & Valving)

Surgical: Repair and Implants

  • Breast Implant and Scaffolding Repair
  • Parastomal Hernia Repair
  • Contraceptive Implant

Tissues

  • Human Tissue Matrix: Pre-IDE studies, Safety & Efficacy trials, Breast Cancer with Mammography
  • Porcine Tissue Matrix: Pre-IDE studies, Safety & Efficacy trials, Breast Cancer with Mammography
  • Colostomy & Breast Repair
  • Diabetic leg ulcers

Miscellaneous Devices

  • Basal Cell Carcinoma Laser
  • Gnathodynamometer Dental Sensitivity Diagnostic Device
  • Flushing Nozzle for Vaginal Cleansing and prevention of STDs and PID

Clinical Expertise

  • Medical Devices
  • Rx – Phase I to IV
  • OTC Consumer Healthcare

Our History of Success

  • Treatment for and Related Conditions Associated with Rhinitis, Asthma, Colds, Coughs

    This review will highlight drugs in the cough/c...
  • Diarrhea, Constipation: Treatment & Related Conditions

    This review will highlight IHC’s expertise as y...

Contact Us To Learn More

International HealthCare (IHC) is a full service contract research organization (CRO) and product development company providing clinical trials and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide.

CLINICAL EXPERTISE

  • Medical Devices
  • Rx – Phase I to IV
  • OTC Consumer Healthcare

IHC SERVICES

  • Project Management
  • Site Management & Monitoring
  • Medical Writing
  • Regulatory Affairs
  • Safety/Ethics Review
  • Data Management / Biostatistics
  • Communication & Training
  • Problem Solvers

ABOUT US

  • IHC Management
  • Resourcing Partnerships
  • Contact Us
  • Download IHC Brochure
IHC provides clinical research services, regulatory strategy and product development for pharmaceutical, biotechnology, and medical device industries. We can assist in designing, monitoring, and managing all phases of your clinical trial.
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© 2020 International HealthCare (IHC) | 98 East Avenue | Norwalk, CT 06851
Phone: (203) 852-8900   |   Email: [email protected]

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