6/26/2024 Updates Meeting

Written By PIcc Alliance

Steering Committee Series

Watch the recording from the meeting.

Download the slides from the meeting here (part 1)

DC Updates

Friends of Cancer

  • An evaluation of novel oncology approvals with a PMR/C for assessing data in racial and ethnic populations underrepresented in premarket clinical trials (download .pdf)

FDA

  • SBIA Event Agenda (download .pdf)

  • Platform Technology Designation Program for Drug Development (download .pdf)

  • Laboratory Developed Tests: Small Entity Compliance Guide Guidance for Laboratory Manufacturers and Food and Drug Administration Staff (download .pdf)

MDIC

Learn more about MDIC’s upcoming APF!

Learn more about MDIC’s upcoming Excellence in Quality Summit!

MDIC Releases Second Annual Medical Device Cybersecurity Maturity Benchmark Report

To read the report, click here.

Cybersecurity

  • Certified Information Privacy Professional/ United States (download .pdf)

Federal Updates

  • Reps. Finstad and Crenshaw, Sen. Paul Introduce Resolution to Repeal Harmful FDA Rule Limiting Access to Laboratory Developed Tests (download .pdf)

  • Artificial Intelligence Risk Management Framework: Generative Artificial Intelligence Profile (download .pdf)

  • Driving U.S. Innovation in Artificial Intelligence (download .pdf)

  • Lack of Reimbursement Hindering AI Adoption, American College of Radiology Warns Congress (download .pdf)

Resources & Publications

  • A vast space of compact strategies for effective decisions (download .pdf)

  • HEST-1k: A Dataset for Spatial Transcriptomics and Histology Image Analysis (download .pdf)

  • Bridging the Clinical-Computational Transparency Gap in Digital Pathology (download .pdf)

  • Spatially aware deep learning reveals tumor heterogeneity patterns that encode distinct kidney cancer states (download .pdf)

  • Artificial Intelligence Helps Pathologists Increase Diagnostic Accuracy and Efficiency in the Detection of Breast Cancer Lymph Node Metastases (download .pdf)

  • Deep learning integrates histopathology and proteogenomics at a pan-cancer level (download .pdf)

  • Parallel genomic analysis from paired bone marrow and peripheral blood samples of 200 cytopenic patients (download .pdf)

  • Pathologists light level preferences using the microscope—study to guide digital pathology display use (download .pdf)

  • Achieving large-scale clinician adoption of AI-enabled decision support (download .pdf)

  • The 1 million words pathology report or the challenge of a reproducible and meaningful message (download .pdf)

  • The evolving landscape of tissue‐agnostic therapies in precision oncology (download .pdf)

  • The three-year evolution of Germany’s Digital Therapeutics reimbursement program and its path forward (download .pdf)

  • Counting Mitosis: SI(ze) Matters! (download .pdf)

  • First looks and fast takes on LDT final rule (download .pdf)

  • Navigating FDA’s Final Rule on Laboratory Developed Tests (download .pdf)

DEI

  • Boost Opportunities for Science Learning With Regional Alliances (download .pdf)

PNPL

PIcc Alliance
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5/29/2024 Updates Meeting