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Every Guidance for Sponsors article, case study and press release from Intrinsic Imaging is available here as a PDF. Use the filters to narrow by type and therapeutic area. Nothing is behind a form.

183 downloads

Intrinsic Imaging

Case study

Pivotal MRMC Study of CAD Software With 14,400 Reviews With and Without CAD

AI/CAD

Intrinsic Imaging

Case study

Tenth MRMC Trial for CAD, AI and Deep Learning Software

AI/CAD

Intrinsic Imaging

Case study

Pivotal MRMC Trial of AI Software Detecting Musculoskeletal Pathology

AI/CAD

Intrinsic Imaging

Case study

Pivotal Device Trial of AI Software for Screening Clinical Images

AI/CAD

Intrinsic Imaging

Case study

Pivotal MRMC Trial of AI Detection Software With 14,000 Radiology Reviews

AI/CAD

Intrinsic Imaging

Case study

Five-Year Multicenter Metastatic Colorectal Cancer Trial Across 40 Sites

Oncology

Intrinsic Imaging

Case study

Four-Year Multinational Phase II Metastatic Breast Cancer Trial Across 60 Sites

Oncology

Intrinsic Imaging

Case study

Breast Cancer Trial With 3,000 Multimodality Breast Imaging Reviews

Oncology

Intrinsic Imaging

Case study

Phase II Metastatic Pancreatic Cancer Trial With RECIST and PERCIST

Oncology

Intrinsic Imaging

Case study

Phase I/II Biologic Trial in Metastatic Colorectal Cancer With Unresectable Liver Metastases

Oncology

Intrinsic Imaging

Case study

Global Hepatocellular Carcinoma Trial With Dynamic Contrast-Enhanced MRI

Oncology

Intrinsic Imaging

Case study

International Phase II Non-Hodgkin Lymphoma Trial With PET/CT and PET/MRI

Oncology

Intrinsic Imaging

Case study

International Phase II Trial in Advanced Squamous Cell Carcinoma

Oncology

Intrinsic Imaging

Case study

Phase II Glioblastoma Multiforme Trial With Central Neuroradiology Review

Oncology

Intrinsic Imaging

Case study

Pivotal Phase III Comparison of an Oral Chemotherapeutic Against the Leading Metastatic Breast Cancer Therapy

Oncology

Intrinsic Imaging

Case study

International Phase III Trial of a Novel Approach to NSCLC Brain Metastases

Oncology

Intrinsic Imaging

Case study

Global Phase III Oral Chemotherapeutic Trial in Metastatic Breast Cancer

Oncology

Intrinsic Imaging

Case study

Phase II Immuno-Oncology Trial in NSCLC and SCLC

Oncology

Intrinsic Imaging

Case study

Phase III NSCLC Brain Metastases Trial With 6,000 Neuroradiology Assessments

Oncology

Intrinsic Imaging

Case study

GIST Trial With RECIST 1.1 and Choi Criteria

Oncology

Intrinsic Imaging

Case study

Neurointerventional Endovascular Device Trial

Medical Device

Intrinsic Imaging

Case study

International Phase III Orthopedic Device Trial With 7,000 Imaging Examinations

Medical Device

Intrinsic Imaging

Case study

Multi-Center Study of a Novel Vascular Device

Medical Device

Intrinsic Imaging

Case study

Clinical Study of a Novel Neurointerventional Device

Medical Device

Intrinsic Imaging

Case study

Four-Year Venous Stent Trial for Symptomatic Venous Outflow Obstruction

Medical Device

Intrinsic Imaging

Case study

International Trial of a Medical Device for the Treatment of Lung Cancer

Medical Device

Intrinsic Imaging

Case study

Genitourinary Device Trial With Dynamic Pelvic Floor MRI

Medical Device

Intrinsic Imaging

Case study

International Phase II Study of a Novel Vascular Device

Medical Device

Intrinsic Imaging

Case study

Interventional Device Trial for Prevention of Pulmonary Emboli

Medical Device

Intrinsic Imaging

Case study

Interventional Device Trial for Percutaneous Tumor Ablation

Medical Device

Intrinsic Imaging

Case study

International Class III Device Trial for Lower Back Pain

Medical Device

Intrinsic Imaging

Case study

Validation Study of a Gastrointestinal Motility Device With a Radiation-Sparing Protocol

Medical Device

Intrinsic Imaging

Case study

Phase II Evaluation of a Novel Tumor Imaging Platform

Medical Device

Intrinsic Imaging

Case study

Cardiovascular Clinical Trial With 1,500 Multimodality Reviews

Cardiovascular & Thoracic

Intrinsic Imaging

Case study

International Phase III Cystic Fibrosis Trial With Structured Chest CT Scoring

Cardiovascular & Thoracic

Intrinsic Imaging

Case study

International Phase II Cardiac Safety Trial With Cardiac MRI

Cardiovascular & Thoracic

Intrinsic Imaging

Case study

Pivotal Multi-Center Acute Ischemic Stroke Trial

Central Nervous System

Intrinsic Imaging

Case study

International Phase III Severe Traumatic Brain Injury Trial Across 100+ Sites

Central Nervous System

Intrinsic Imaging

Case study

Five-Year International Phase II Iron Overload Trial With 4,500 MRI Scans

Gastroenterology & Metabolic

Intrinsic Imaging

Case study

Three-Year International Phase II Trial in Chronic Iron Overload

Gastroenterology & Metabolic

Intrinsic Imaging

Case study

Global Phase II Arthritis Trial With Quantitative Joint Imaging

Musculoskeletal

Intrinsic Imaging

Case study

Pivotal Phase II Biologic Trial in a Rare Degenerative Neuromuscular Disorder

Musculoskeletal

Intrinsic Imaging

Case study

Obesity Trial With DXA Body Composition and MRI Fat Quantification

Gastroenterology & Metabolic

Intrinsic Imaging

Case study

Imaging Core Lab Support Through NDA Submission and FDA Inspection

Oncology

Intrinsic Imaging

Case study

Multiple Myeloma Trial With IMWG Imaging Criteria

Oncology

Intrinsic Imaging

Case study

ARIA Safety Monitoring in an Anti-Amyloid Alzheimer's Trial

Central Nervous System

Intrinsic Imaging

Case study

Radioligand Therapy Trial With PSMA PET Eligibility and Dosimetry

Oncology

Intrinsic Imaging

Case study

Idiopathic Pulmonary Fibrosis Trial With Quantitative HRCT

Cardiovascular & Thoracic

Intrinsic Imaging

Case study

Phase I/IIa Imaging Endpoint Strategy for a Biotech Go/No-Go Decision

Oncology

Intrinsic Imaging

Case study

Imaging Data Transfer and Query Resolution Integrated With Sponsor EDC

Cardiovascular & Thoracic

Intrinsic Imaging

Case study

Rare Disease Cardiomyopathy Trial With Echo and Cardiac MRI

Cardiovascular & Thoracic

Intrinsic Imaging

Case study

ADPKD Trial With Total Kidney Volume MRI

Gastroenterology & Metabolic

Intrinsic Imaging

Case study

Cervical Disc Replacement IDE Trial With Range-of-Motion Analysis

Medical Device

Guidance for Sponsors

Quantitative Neuroimaging of Alzheimer's Disease

Central Nervous System

Guidance for Sponsors

Traumatic Brain Injury: Medical Imaging in Clinical Trials

Central Nervous System

Guidance for Sponsors

Imaging and Monitoring Tumor Response in Clinical Trials

Oncology

Guidance for Sponsors

Complex Spinal Deformities: Medical Imaging in Clinical Trials

Musculoskeletal

Guidance for Sponsors

Advances in Imaging of Rheumatoid Arthritis

Musculoskeletal

Guidance for Sponsors

Tissue Iron Deposition: MRI Quantitation in Clinical Trials

Cardiovascular & Thoracic

Guidance for Sponsors

Neurological Imaging: Contrast Enhancement in Clinical Trials

Central Nervous System

Guidance for Sponsors

Metastatic Colorectal Cancer and Locoregional Therapies

Oncology

Guidance for Sponsors

WHO, RECIST, EASL, mRECIST and Cheson: Challenges of Evaluating Tumor Response

Oncology

Guidance for Sponsors

Inferior Vena Cava Filters: Medical Imaging in Clinical Trials

Cardiovascular & Thoracic

Guidance for Sponsors

Immunotherapy and Imaging of Metastatic Pancreatic Adenocarcinoma

Oncology

Guidance for Sponsors

Advances in Imaging of Non-Small Cell Lung Cancer (NSCLC)

Oncology

Guidance for Sponsors

Functional Imaging of the Dopamine Pathway

Central Nervous System

Guidance for Sponsors

Temporal Lobe Epilepsy and Volumetric MRI in Clinical Trials

Central Nervous System

Guidance for Sponsors

irRECIST and Immuno-Oncology in Clinical Trials

Oncology

Guidance for Sponsors

Contrast Echocardiographic Imaging in Clinical Trials

Cardiovascular & Thoracic

Guidance for Sponsors

Coronary Artery Calcium Scoring in Clinical Trials

Cardiovascular & Thoracic

Guidance for Sponsors

The Challenge of Quantitative Measurements of Primary Brain Tumors in Clinical Trials

Central Nervous System

Guidance for Sponsors

Medical Imaging of Osteoarthritis of the Knee in Clinical Trials

Musculoskeletal

Guidance for Sponsors

Medical Imaging of Chronic Lymphocytic Leukemia

Oncology

Guidance for Sponsors

Quantitative MRI Imaging in Orthopedic Clinical Trials

Musculoskeletal

Guidance for Sponsors

Magnetic Resonance Elastography: A Quantitative Endpoint for Liver Fibrosis Trials

Gastroenterology & Metabolic

Guidance for Sponsors

Screening Mammography AI: A Continued Market Opportunity

AI/CAD

Guidance for Sponsors

Oncologic Imaging: The Benefits of Diffusion-Weighted MRI

Oncology

Guidance for Sponsors

Imaging Analysis and Operative Treatment of Diaphyseal Fractures

Musculoskeletal

Guidance for Sponsors

Orthopedic Device Assessments: Medical Imaging Challenges in Clinical Trials

Musculoskeletal

Guidance for Sponsors

The Challenges of Reducing Lung Cancer Mortality with Screening

Oncology

Guidance for Sponsors

Computed Tomography Data Acquisition in Clinical Trials

Oncology

Guidance for Sponsors

Advances in High-Field MRI for the Assessment of Arthritis

Musculoskeletal

Guidance for Sponsors

Muscular Dystrophy: Medical Imaging in Clinical Trials

Musculoskeletal

Guidance for Sponsors

Echocardiography: Advantages in Clinical Trials

Cardiovascular & Thoracic

Guidance for Sponsors

Osteoporosis Therapy: Challenges in Monitoring Efficacy in Clinical Trials

Musculoskeletal

Press release

Intrinsic Imaging Announces Acquisition, Accelerating Global Expansion as a Leading Imaging Core Lab

Press release

Intrinsic Imaging Core Lab Announces its Acquisition for $80 Million

Press release

Intrinsic Imaging Undergoes Third FDA Inspection with No 483 Observations

Press release

Intrinsic Imaging Undergoes Extensive FDA BIMO Inspection — Receives Zero 483 Observations

Press release

Intrinsic Imaging Publishes Results of Artificial Intelligence (AI) Pivotal Study in the American Journal of Roentgenology

Press release

ISO Certified Intrinsic Imaging Core Lab Completes Very Large 12,480 Read Pivotal Oncology Clinical Trial in 5 Weeks

Press release

Leading Artificial Intelligence Company Selects Intrinsic Imaging to Conduct Pivotal Clinical Trial to Support FDA Submission

AI/CAD

Press release

Intrinsic Imaging Selected by an Emerging Artificial Intelligence (AI) Company for Pivotal Medical Device Clinical Trial

AI/CAD

Press release

Intrinsic Imaging Selected by Emerging AI Company for Pivotal Medical Device Clinical Trial

AI/CAD

Press release

Intrinsic Imaging Awarded Pivotal Phase II Clinical Trial Focused on Treatment of Degenerative Neuromuscular Disorder

Musculoskeletal

Press release

Intrinsic Imaging Awarded Its Tenth Clinical Trial for Computer Aided Detection (CAD) / Artificial Intelligence (AI) / Deep Learning (DL) Software

AI/CAD

Press release

Intrinsic Imaging Awarded New Clinical Study to Evaluate Innovative Tumor Imaging Platform

Medical Device

Press release

Intrinsic Imaging Awarded a Validation Study for the Development of an Innovative Medical Device to Aid in the Evaluation of Gastrointestinal Motility

Medical Device

Press release

Intrinsic Imaging Awarded Another Pivotal Multiple-Reader Multiple-Case (MRMC) Study to Assess the Clinical Performance of CAD Software

AI/CAD

Press release

Intrinsic Imaging Awarded GIST Clinical Trial for the Treatment of Gastrointestinal Stromal Tumors

Oncology

Press release

Intrinsic Imaging Awarded Phase III Clinical Trial Focused on Brain Metastases of Non-Small Cell Lung Cancer (NSCLC)

Oncology

Press release

Intrinsic Imaging Awarded Phase II Immuno-Oncology Clinical Trial for the Treatment of Non-Small Cell Lung Cancer and Small Cell Lung Cancer

Oncology

Press release

Intrinsic Imaging's Quality Management System Attains ISO 27001 Informational Security Certification

Press release

Intrinsic Imaging Awarded International Clinical Trial to Determine Efficacy of Innovative Class III Medical Device

Medical Device

Press release

Intrinsic Imaging Awarded Large Pivotal Phase III Oncology Trial for Metastatic Breast Cancer

Oncology

Press release

Intrinsic Imaging Awarded International Phase III Trial for Novel Treatment of Non-Small Cell Lung Cancer Brain Metastases

Oncology

Press release

Intrinsic Imaging at ASCO 2016

Press release

Intrinsic Imaging Sponsors Webinar: Medical Imaging — The Advantages of an ISO Certified Quality Management System

Press release

Intrinsic Imaging Awarded International Phase II Trial for Arthritis

Musculoskeletal

Press release

Clinical Trial Sponsors Agree Intrinsic Imaging Core Lab Provides Exceptional Quality

Press release

Todd Joron, Intrinsic Imaging's President and COO, to Speak at Imaging in Clinical Trials, March 29–30 in Philadelphia

Press release

Intrinsic Imaging's ISO Certified Quality Management System to be Featured at the Imaging in Clinical Trials Event

Press release

Intrinsic Imaging Awarded Pivotal Phase III Trial to Assess Novel Oral Chemotherapeutic for Metastatic Breast Cancer

Oncology

Press release

Intrinsic Imaging Awarded Medical Device Trial for Percutaneous Tumor Ablation

Medical Device

Press release

Intrinsic Imaging Awarded Phase II Clinical Trial for Glioblastoma Multiforme

Oncology

Press release

Intrinsic Imaging Awarded Phase II Clinical Trial for Advanced Squamous Cell Carcinoma

Oncology

Press release

Intrinsic Imaging Awarded Interventional Medical Device Trial for Prevention of Pulmonary Emboli

Medical Device

Press release

Intrinsic Imaging Reports Exceptional 2014 Customer Satisfaction Survey Results

Press release

Intrinsic Imaging Expands Its Medical Imaging Consulting Group for Clinical Trials

Press release

Intrinsic Imaging Awarded Phase II Clinical Trial to Assess New Treatment for Non-Hodgkins Lymphoma

Oncology

Press release

Intrinsic Imaging Awarded International Phase II Study for Novel Vascular Medical Device

Medical Device

Press release

Intrinsic Imaging Awarded Genitourinary Medical Device Clinical Trial

Medical Device

Press release

Intrinsic Imaging ISO 13485 Medical Device Certification Leads to Award of Lung Cancer Clinical Trial

Medical Device

Press release

Intrinsic Imaging Awarded Landmark Medical Device Trial for Treatment of Symptomatic Venous Outflow Obstruction

Medical Device

Press release

Intrinsic Imaging Awarded Global Clinical Trial for Hepatocellular Carcinomas

Oncology

Press release

Intrinsic Imaging Obtains ISO 22301:2012 Business Continuity Management System Certification

Press release

Intrinsic Imaging Awarded Clinical Study for Novel Neurointerventional Medical Device

Medical Device

Press release

Intrinsic Imaging Obtains ISO 13485 Medical Device Certification

Press release

Intrinsic Imaging Undergoes Extensive Quality Audit — Receives Zero Observations

Press release

Intrinsic Imaging Core Lab Expertise Contributes to Another FDA Approval

Press release

Intrinsic Imaging Awarded Phase II Clinical Trial for Cardiovascular Disease

Cardiovascular & Thoracic

Press release

Intrinsic Imaging Awarded Multi-Center Study for a Novel Vascular Medical Device

Medical Device

Press release

Intrinsic Imaging Awarded International Phase II Clinical Trial for Chronic Iron Overload

Gastroenterology & Metabolic

Press release

Metastatic Colorectal Cancer (mCRC) Phase I/II Trial Awarded to Intrinsic Imaging

Oncology

Press release

Intrinsic Imaging Awarded Large 5 Year International Phase II Clinical Trial to Treat Iron Overload

Gastroenterology & Metabolic

Press release

Intrinsic Imaging Opens Medical Imaging Office in Greater Boston

Press release

BSI Awards ISO 13485:2003 Quality Certification to Intrinsic Imaging

Press release

Orthopedic Medical Device Phase III Clinical Trial Awarded to Intrinsic Imaging

Medical Device

Press release

Intrinsic Imaging Awarded Large International Phase III Clinical Trial for the Treatment of Severe Traumatic Brain Injury

Central Nervous System

Press release

Intrinsic Imaging Undergoes Extensive FDA Audit – Receives Zero 483 Observations

Press release

Intrinsic Imaging Awarded International Phase III Clinical Trial for Cystic Fibrosis

Cardiovascular & Thoracic

Press release

Intrinsic Imaging Awarded Phase II Trial for Metastatic Pancreatic Cancer

Oncology

Press release

Intrinsic Imaging Core Lab Expertise Contributes to FDA Clearance of Medical Device

Press release

Intrinsic Imaging Implements ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems

Press release

Intrinsic Imaging Awarded Cardiovascular Clinical Trial

Cardiovascular & Thoracic

Press release

Intrinsic Imaging Awarded Important Clinical Trial for the Evaluation of Breast Disease

Oncology

Press release

Intrinsic Imaging Obtains ISO 9001:2008 Quality Certification by World Leading Certification Body

Press release

Neurointerventional Medical Device Clinical Trial Awarded to Intrinsic Imaging

Medical Device

Press release

Intrinsic Imaging Awarded Multinational Phase II Trial for the Study of Metastatic Breast Cancer

Oncology

Press release

Intrinsic Imaging Joins Metastatic Colorectal Cancer Trial

Oncology

Press release

Intrinsic Imaging Awarded Pivotal Multi-Center Clinical Trial for Acute Ischemic Stroke

Central Nervous System

Press release

Omnicare to Employ Merge Clinical Trial Imaging Application — Featuring Intrinsic Imaging

Press release

Intrinsic Imaging's Quality Management System Attains ISO 9001:2008 Compliance

Press release

Intrinsic Imaging Establishes Global Imaging Center Consortium for Multi-Center Clinical Trials

Press release

Intrinsic Imaging Appoints Leading Vascular and Interventional Radiologist Dr. Amit Mehta as Vice President and Chief Medical Officer

Press release

Intrinsic Imaging Publishes Its Metrics Champion Consortium Imaging Performance Targets

Press release

Intrinsic Imaging and Merge Healthcare Announce Technology Agreement

Press release

Announcing Intrinsic Imaging – Radiology Experts Launch Novel Medical Imaging Core Lab for Clinical Trials

Intrinsic Imaging

Case study

Rescuing a Global Phase III Solid Tumor Trial

Oncology

Intrinsic Imaging

Case study

Phase III Immunotherapy RECIST and iRECIST

Oncology

Intrinsic Imaging

Case study

MRMC Reader Study for AI 510(k) Submission

AI/CAD

Intrinsic Imaging

Case study

Phase II Alzheimer's Amyloid PET and MRI

Central Nervous System

Intrinsic Imaging

Case study

IDE Pivotal Transcatheter Valve Trial

Medical Device

Intrinsic Imaging

Case study

Global Cardiovascular Trial With CCTA and MRI

Cardiovascular & Thoracic

Intrinsic Imaging

Case study

Phase III Knee Osteoarthritis DMOAD Trial

Musculoskeletal

Intrinsic Imaging

Case study

Phase IIb Inflammatory Bowel Disease Trial

Gastroenterology & Metabolic

Intrinsic Imaging

Case study

Geographic Atrophy and Neovascular AMD Trial

Ophthalmology

Intrinsic Imaging

Case study

Fast-Track Rare Disease Oncology Trial

Oncology

Intrinsic Imaging

Case study

Mid-Study Transfer of a Phase III MS MRI

Central Nervous System

Intrinsic Imaging

Case study

Rescuing a Stalled Peripheral Vascular Trial

Medical Device

Intrinsic Imaging

Case study

Lymphoma Trial Using Lugano Classification

Oncology

Intrinsic Imaging

Case study

Glioblastoma Trial With RANO Criteria

Oncology

Intrinsic Imaging

Case study

Metastatic Prostate Cancer With PCWG3 Review

Oncology

Intrinsic Imaging

Case study

Hepatocellular Carcinoma Trial Using mRECIST

Oncology

Intrinsic Imaging

Case study

Ground Truth for a Breast Cancer Detection AI

AI/CAD

Intrinsic Imaging

Case study

Chest CT Lung Nodule MRMC Reader Study

AI/CAD

Intrinsic Imaging

Case study

Spinal Fusion Device Trial With Fusion Review

Medical Device

Intrinsic Imaging

Case study

Parkinson's Trial With DaT-SPECT Imaging

Central Nervous System

Intrinsic Imaging

Case study

Heart Failure Trial Echocardiography Core Lab

Cardiovascular & Thoracic

Intrinsic Imaging

Case study

Rheumatoid Arthritis Modified Sharp Scoring

Musculoskeletal

Intrinsic Imaging

Case study

NASH Trial With MRI-PDFF and Liver Stiffness

Gastroenterology & Metabolic

Intrinsic Imaging

Case study

Diabetic Macular Edema Trial OCT Endpoints

Ophthalmology

Intrinsic Imaging

Case study

Rapid Pediatric Neuroblastoma Trial Startup

Oncology