4/24/2024 Updates Meeting
Steering Committee Series
Watch the recording from the meeting.
Regulatory Landscape Survey (download .pdf)
FDA
2023 Annual Report Center for Devices and Radiological Health (download .pdf)
2024 CDRH Innovation Report (download .pdf)
MDDT Summary of Evidence and Basis of Qualification for The University of California San Francisco (UCSF) Lethal Arrhythmia Database (LAD) (download .pdf)
2024 CDRH Safety Report (download .pdf)
Your Clinical Decision Support Software: Is It a Device? (download .pdf)
510(k) Substantial Equivalence Determination Decision Summary: Leica Biosystems Imaging, Inc. (download .pdf)
510(k) Substantial Equivalence Determination Decision Summary: Sectra AB (download .pdf)
EU and Beyond
Generative AI Models Opportunities and Risks for Industry and Authorities (download .pdf)
Generative KI-Modelle Chancen und Risiken für Industrie und Behörden (download .pdf)
Environnement digital et santé des populations (download .pdf)
Report on AI-based Software as a Medical Device (SaMD) (download .pdf)
CLIA
The Basics of Artificial Intelligence and Machine Learning (download .pdf)
CHA Challenges (download .pdf)
FDA CLIAC Updates (download .pdf)
Resources & Publications
Fast-track Development and Multi-Institutional Clinical Validation of an Artificial Intelligence Algorithm for Detection of Lymph Node Metastasis in Colorectal Cancer (download .pdf)
Embracing Cancer Complexity: Hallmarks of Systemic Disease (download .pdf)
Deep Representation Learning of Tissue Metabolome and Computed Tomography Annotates NSCLC Classification and
If it’s a Target, it’s a Pan-Cancer Target: Tissue is Not the Issue (download .pdf)
Risk–Benefit Trade-Offs and Precision Utilities in Phase I-II Clinical Trials (download .pdf)
Single Cell Atlas: A Single-Cell Multi-Omics Human Cell Encyclopedia (download .pdf)
PERCEPTION Predicts Patient Response and Resistance to Treatment Using Single-Cell Transcriptomics of their Tumors (download .pdf)
A Vision for Democratizing Next-Generation Oncology Clinical Trials (download .pdf)
Accelerating Drug Development Using Spatial Multi-omics (download .pdf)
Data Extraction from Free-Text Reports on Mechanical Thrombectomy in Acute Ischemic Stroke Using ChatGPT: A Retrospective Analysis (download .pdf)
Radiologist Workforce Changes: Going Remote or Hybrid (download .pdf)
Advancing Precision Medicine: Algebraic Topology and Differential Geometry in Radiology and Computational Pathology (download .pdf)
Programmed Death Ligand-1 and Tumor Mutation Burden Testing of Patients With Lung Cancer for Selection of Immune Checkpoint Inhibitor Therapies (download .pdf)
Tumor Histoculture Captures the Dynamic Interactions Between Tumor and Immune Components in Response to anti-PD1 in Head and Neck Cancer (download .pdf)
Neoadjuvant Nivolumab or Nivolumab plus LAG-3 Inhibitor Relatlimab in Resectable Esophageal/Gastroesophageal Junction Cancer: a Phase Ib Trial and ctDNA Analyses (download .pdf)
CORAL: Expert-Curated Oncology Reports to Advance Language Model Inference (download.pdf)
The Clinician-AI Interface: Intended Use and Explainability in FDA-Cleared AI Devices for Medical Image Interpretation (download .pdf)
Guardrails for the Use of Generalist AI in Cancer Care (download .pdf)
The Antibody–Drug Conjugate Landscape (download .pdf)
Precision Needle-Punch Tumor Enrichment from Paraffin Blocks Improves the Detection of Clinically Actionable Genomic Alterations and Biomarkers (download .pdf)
Extracting Interpretable Features for Pathologists Using Weakly Supervised Learning to Predict P16 Expression in Oropharyngeal Cancer (download .pdf)
Pathologic Assessment and Staging of Multiple NoneSmall Cell Lung Carcinomas: A Paradigm Shift with the Emerging Role of Molecular Methods (download .pdf)
Quantitative Measurement of HER2 Expression to Subclassify ERBB2 Unamplified Breast Cancer (download .pdf)
Epigenetically Upregulating TROP2 and SLFN11 Enhances Therapeutic Efficacy of TROP2 Antibody Drug Conjugate Sacitizumab Govitecan (download .pdf)
Accelerating the Development of Genetically Engineered Cellular Therapies: A Framework for Extrapolating Data Across Related Products (download .pdf)
Identifying Low Levels of HER2 Expression in Breast Cancer (download .pdf)
HER2 IHC Interpretation: A Quick Reference Guide (download .pdf)
HER2 Expression in Breast Cancer: A Comprehensive Reference for IHC Analysis (download .pdf)
The Wild, Wild West Laboratory Developed Tests (download .pdf)
Mastering Complexity: The Path Towards a Cancer-Free Reality (download .pdf)
ADLM Member Feedback: Assessing Responses to FDA's Proposed LDT Regulation Survey (download .pdf)
Generative AI for the Public Sector: The Journey to Scale (download .pdf)
A Distinct Fusobacterium nucleatum Clade Dominates the Colorectal Cancer Niche (download .pdf)
Understanding the Financial Aspects of Digital Pathology: A Dynamic Customizable Return on Investment Calculator for
Informed Decision-Making (download .pdf)
Tissue-specific Genetic Variation Suggests Distinct Molecular Pathways Between Body Shape Phenotypes and Colorectal Cancer (download .pdf)
Supplementary Material (download .pdf)