Experience Counts.

Novella's dedicated team serves only medical device and diagnostic companies. Led by a management team with over 25 years operational leadership, each project team member is a fully dedicated device expert, and most have deep histories with sponsor companies. Novella's professionals understand the intricacies and nuances of device trials, and unlike many CROs, Novella has the global footprint, regulatory acumen and quality management systems to serve your trial well.

Novella's corporate experience spans the following:

  • 510(k)
  • Investigational Device Exemption (IDE) Premarket Approval (PMA)
  • Feasibility/Proof of Concept
  • Pivotal
  • Post Market Support/Registry
  • Health Economics & Reimbursement
  • Combination Products
  • Biologics
  • Human Factors
  • In Vitro Diagnostics

Novella serves the following therapeutic areas:

  • Cardiovascular
    • CHF (congestive heart failure), CAD (coronary artery disease), Angina, HTN (hypertension), Dysrhythmia, Aortic Aneurysms, PVD (peripheral vascular disease)
  • Orthopedic
    • DDD (degenerative disc disease), AVN (avascular necrosis), three piece ankle
  • CNS/Neurology
    • Spinal cord injury, compression fractures, pain
  • Oncology
    • Prostate
    • Liver
  • General Surgery
    • Wound Healing
    • Urology
    • Women's Health
    • Nephrology
    • Endocrinology
   

Medical Device & Diagnostic Experience:

  • Ventricular assist devices (VADs)
  • Bare metal and drug-eluting stents
  • Stent grafts
  • Stem cells
  • Alginates
  • Pacemakers
  • Cardiac leads
  • Implantable Cardioverter-Defibrillators (ICD)
  • Ablation catheters
  • Spine fixation hardware
  • Full and partial knee replacement hardware
  • Hip replacement device & hardware
  • Shoulder hardware
  • Spinal cord neurostimulator
  • Transdermal patch
  • Bone cement
  • Lumbar fusion device
  • Septal closure device

Interesting in learning more about how Novella's Medical Device and Diagnostics division works? 


Bullet Graphic  Download our fact sheet here.

 

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