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Medical Imaging Industry Quarterly Tracker, Q2 2019

  • Report

  • 73 Pages
  • November 2019
  • Region: Global
  • Frost & Sullivan
  • ID: 4869647

Quarterly Edition of Trends in Medical Imaging and Informatics, Covering Competition, Policy, Regulatory, and Clinical Areas

The medical imaging and informatics industry is evolving rapidly, and new products and solutions are launched every other day. As the reimbursement environment is transitioning from fee-for-service to value-based payment, vendors’ business models and value propositions are undergoing drastic changes. New evidence regarding the use of certain techniques in imaging is influencing changes in the standard of care. On a macro level, the government's policies on reimbursement and regulations tend to impact the performance of industry participants, if their internal teams delay the calibration of the strategic actions needed to thrive in this new environment.

To help its clients address challenges in an intensely competitive environment, the publisher has introduced the Medical Imaging and Informatics Quarterly Insights tracker that will monitor market factors and significant events and qualitatively assess their impact on the industry; this will cover the diagnostic imaging, image-guided therapies, and imaging informatics segments.

Research Scope

The scope of this deliverable covers the following segments

Clinical Trends

  • Disruptive trends impacting the current ‘gold standard’
  • Trends indicating the clinical adoption of new solutions /products
  • Important announcements from associations, such as RSNA, ESR, ACR, and ACC


  • New product launches and capabilities
  • Mergers & acquisitions
  • FDA & CE approvals
  • Major FDA & CE recalls/warnings

Policy and Regulations

  • Region-specific introduction of new regulatory approvals
  • Reimbursement achievements or setbacks

Event Highlights

  • Major events highlights in the quarter covering the major themes, derived by studying the messaging and communications, product launches, and product promotions at the event

Table of Contents

1. Executive Summary
  • Research Scope

2. Competitive Analysis
  • Long-term Business Contracts - Customer Acquisitions
  • New Launches and Upgrades
  • Mergers and Acquisitions
  • Strategic Collaborations
  • FDA Approvals for Products of Top Tier Participants (April-June 2019)
  • FDA Approvals for Products of Other Participants (April-June 2019)
  • Notable CE Approvals
  • FDA Recalls
  • Analyst Perspective

3. Policies and Regulations
  • Proposed Electronic Health Information Interoperability Rules
  • USFDA's Final Guidelines for Regulatory Standards for Medical Imaging Equipment
  • CMS Mandates CDS Software for Ordering Medical Imaging Decisions
  • Guidelines for Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
  • Technical Considerations and Imaging Techniques for Valvular Regurgitation
  • Draft Premarket Recommendations for Manufacturers on Quantitative Medical Imaging
  • Royal College of Radiologists Reports Shortage of Radiologists in UK
  • UK Royal College of Radiologists Issues Guidance On The Administration of Gadolinium-based Contrast Agents
  • NMPA's New Guidelines for the Medical Devices Industry Standards
  • Technical Guideline on Artificial Intelligence Software, 2019
  • Tightened Regulations for Medical Imaging Devices In India
  • Public-Private Partnership for Radiology and Medical Imaging Services
  • Diagnostic Imaging and Radiation Oncology Practices Eligibility for Medicare Benefits

4. Clinical Trends
  • Ga-68 PSMA PET/CT, the Modality of Choice for Staging of Prostate Cancer
  • Discovery of Higher Incidence in Women during China's Lung Cancer CT Screening
  • Better Patient Outcomes with Intravascular Ultrasound
  • Coronary Angiography after Cardiac Arrest without ST-Segment Elevation
  • Magnetic Resonance Perfusion Versus Fractional Flow Reserve in Stable Angina
  • Accuracy of Whole-body MRI in Lung and Colon Cancers
  • American Medical Association (AMA) Approval of Four New CPT Codes for 3D Printing
  • Tripling of Digital Breast Tomosynthesis (DBT) Adoption in 3 Years
  • Release of the American Society of Breast Surgeons (ASBrS) Position Statement on Risk-based Breast Screening and DBT
  • Electromechanical Wave Imaging Proving Superior to Electrocardiogram (ECG) in Mapping Cardiac Arrhythmias

5. Events
  • Trending Themes at the 2018 AIUM Convention, April 2019
  • Trending Themes at the ESTRO 38, April 2019
  • Trending Themes at the ISMRM 27th Annual Meeting & Exhibition, May 2019
  • Trending Themes at the SIIM19 Annual Meeting, June 2019

6. Conclusion
7. Appendix
  • List of Exhibits
  • List of Abbreviations
  • Legal Disclaimer

Companies Mentioned

A selection of companies mentioned in this report includes:

  • ACC
  • ACR
  • American Medical Association (AMA)
  • American Society of Breast Surgeons (ASBrS)
  • CE
  • CMS
  • ESR
  • FD
  • Royal College of Radiologists
  • RSNA