Agenda:

• FDA Guidance:

  • ctDNA OOTD Guidance Review Session on July 21 at 11AM ET (link)

    • FOCR ctMoniTR project event July 20 at 11:30AM ET (link)

  • Cybersecurity in Medical Devices (link)

    • Bill - Healthcare Cybersecurity Act of 2022 (link)

    • Article - FDA Document Details Cyber Expectations for Device Makers (link)

    • Bill - Strengthening Cybersecurity for Medical Devices Act (link)

    • Article - Bill Calls for Frequent FDA Device Cyber Guidance Updates (link)

  • Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions  (link)

• European AI Law

• HHS withdrawing the SUNSET final rule

  • Article - HHS finishes off Trump-era rule that would've erased basic FDA regs without frequent reviews (link)

  • Economic Impact Analyses of FDA Regulations (link)

• CPT Coding

• CURE ID (link) (collaboration between FDA and the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH))

• Relevant books:

  • Uta Schmidt-Strasßburger. Improving Oncology Worldwide

    • Master of Advanced Oncology Course

  • Ronald Christensen. Analysis of Variance, Design, and Regression: Applied Statistical Methods

  • Kroese et al. Data Science and Machine Learning: Mathematical and statistical methods

• Featured work:

  • Brian Ford – History of AI (link)

  • QUAREP-LiMi (link)

  • Margaretta Colangelo (link)

  • PathML (link)

  • MedTech Color Collaborative Community Annual Report

  • American Board of Pathology Annual Report

  • The Commonwealth Fund Meeting America’s Public Health Challenge

• Featured papers:

  • Diamantopoulou et al. The metastatic spread of breast cancer accelerates during sleep

    • Ball & Nagrath. Cancer cells spread aggressively during sleep

  • Drews et al. A pan-cancer compendium of chromosomal instability

  • Gounder et al. Clinical genomic profiling in the management of patients with soft tissue and bone sarcoma

  • Jorgenson. Missing Companion Diagnostic for US Food and Drug Administration–Approved

  • Lips et al. Genomic analysis defines clonal relationships of ductal carcinoma in situ and recurrent invasive breast cancer

  • Maier-Hein et al. BIAS: Transparent reporting of biomedical image analysis challenges

  • Mund et al. Unbiased spatial proteomics with single-cell resolution in tissues

  • Nacev et al. Clinical sequencing of soft tissue and bone sarcomas delineates diverse genomic landscapes and potential therapeutic targets

  • Park et al. Artificial Intelligence–Powered Spatial Analysis of Tumor-Infiltrating Lymphocytes as Complementary Biomarker for Immune Checkpoint Inhibition in Non–Small-Cell Lung Cancer

  • Reinke et al. Common Limitations of Image Processing Metrics: A Picture Story

  • Sherman et al. Genome-wide mapping of somatic mutation rates uncovers drivers of cancer