Indiana University School Of Medicine

Most medical devices, including implants, lack rigorous FDA safety standards, leading to avoidable harm and recalls. Critics urge more science in FDA approval processes, highlighting issues with clinical trial standards and follow-up periods. Public pressure to expedite approvals may exacerbate these problems, with device makers often protected from lawsuits post-FDA approval. Patients should be informed of potential device risks before implantation.

Laura J. van ’t Veer, PhD, to receive the William L. McGuire Memorial Lecture Award at SABCS 2024 for her contributions in breast cancer research, including the development of MammaPrint and leadership in the I-SPY 2 trials.

FDA approves Cologuard Plus for colorectal cancer screening; advancements in breast cancer care include genomic testing; HBI0101 CAR T-cell therapy shows promise in multiple myeloma; neoadjuvant nivolumab plus chemotherapy approved for NSCLC; Belantamab mafodotin-blmf combo demonstrates efficacy in relapsed/refractory multiple myeloma.

Dr. Marcelino E. Rivera discusses advancements in stone disease and BPH treatment, highlighting steerable suction catheters and scopes, miniPCNL, CVAC scope, and suction steerable ureteral access sheaths. He also emphasizes the importance of tailored procedures and educational advancements in HoLEP and enucleation training.

The American Medical Association has launched the next phase of ChangeMedEd®, focusing on competency-based medical education, transitions, precision education, and equity. New groundwork teams and Innovation Grant recipients are developing and piloting innovations at various medical schools. The ChangeMedEd Consortium aims to promote systemic change in medical education.

Exact Sciences Corp. announced FDA approval of Cologuard Plus, a next-gen multitarget stool DNA test for CRC screening in adults 45+; based on BLUE-C study, it showed 95% overall cancer sensitivity and 43% for advanced precancerous lesions at 94% specificity. The test aims to improve early detection and reduce false positives, building on the success of the original Cologuard test.

A new geriatric care curriculum for nursing students, developed by Regenstrief Institute and Indiana University School of Medicine, aims to refine long-term care and address the nursing shortage. It includes 10 hours of online learning on LTC topics and uses virtual, simulated patients for real-time feedback, enhancing skills applicable across various nursing environments. The goal is to improve geriatric care, positively impacting older adults' outcomes and quality of life.

FDA approves Exact Sciences' Cologuard Plus test, which detects colorectal cancer and precancerous polyps with greater sensitivity and fewer false positives. The test, developed with Mayo Clinic, is approved for adults aged 45+ and aims to improve screening rates.

FDA approves Exact Sciences' Cologuard Plus for CRC screening in adults 45+ with average risk, based on BLUE-C study results showing 95% sensitivity for CRC and 43% for advanced precancerous lesions. The test, set to launch in 2025, aims to improve early detection and reduce false positives.