NATIONAL INSTITUTES OF HEALTH

Advarra's Gene Therapy Ready (GTR) global site network expands to 1,500 sites to support and accelerate cell and gene therapy trials, offering NIH-compliant IBC oversight and faster trial startup for sponsors and CROs.

Pi-Cardia received FDA clearance for its Shortcut device to reduce coronary obstruction risk in valve-in-valve TAVR procedures by splitting aortic valve leaflets. The device aims to address concerns of valve failure in younger patients with longer life expectancies, offering a safer alternative to repeat or open-heart surgery. Shortcut, granted breakthrough device designation in January, uses a blade to mechanically split leaflets, differing from the NIH's Basilica device, which requires highly skilled operators. Pi-Cardia plans a limited launch with a commercial and clinical support team, anticipating that 30% of future TAVR cases may need leaflet modification.

Researchers at Fred Hutch Cancer Center identify SLC35A2 protein favoring R5 HIV-1 variants over X4, potentially aiding vaccine development.

The Synthesis Modules for Radiotracers Market was valued at USD 1.20 Billion in 2023 and is projected to reach USD 2.27 Billion by 2032, growing at a CAGR of 7.66%. Technological advancements and increased demand for personalized medicine drive market growth.

Healthcare informatics, integrating data, technology, and healthcare, is revolutionizing patient care, operational efficiency, and delivery through EHRs, telemedicine, mHealth apps, AI, precision medicine, and blockchain. Challenges include data privacy, interoperability, digital divide, and ethics. Future advancements promise personalized medicine and holistic patient views.

An NIEHS-supported study by Million Marker and University of Nevada researchers aimed to reduce participants' exposure to endocrine-disrupting chemicals (EDCs) through improved environmental health literacy. Participants' EDC levels were measured via urinalysis, and personalized reports detailing health effects and exposure reduction methods were provided. The study, published in July 2024, found that participants successfully used the information to reduce EDC exposure, with notable reductions in phthalates detected in urine samples post-intervention.

UMass Chan Medical School study finds variations in antidementia and antipsychotic drug use among US nursing home residents with dementia, suggesting a need for better guidance. Antipsychotic use was higher in facilities with poorer staffing quality and physical restraints, while antidementia drug use was linked to higher health care utilization areas.

NIH's NIAID selects Emergex's T cell-priming vaccine candidate for Betacoronaviruses for clinical trials under Project NextGen, aiming to induce variant-agnostic, durable cell-mediated immunity and reduce the need for frequent booster vaccinations.

Study reveals inconsistencies and lack of transparency in FDA AI/ML approval documents, highlighting potential health disparities. Only 37% of documents provided sample size information, 14.5% included race/ethnicity data, and 19.4% provided age information. Recommendations include explicit representation standards, inclusive validation criteria, transparency requirements, post-market surveillance for equity, interdisciplinary review panels, and incentives for diversity and equity.

650 bilateral EVLP cases (2008-2022) at Toronto General Hospital, with 1300 radiographs, were split 80:20 into training and validation sets. CNN architectures (ResNet-50, ResNeXt-50, RexNet-100, EfficientNet-B2/B3, DenseNet-121) were pretrained on ChestX-ray14 datasets and finetuned on EVLP radiographs for lung transplant outcome classification. Model performance was evaluated using accuracy and AUROC. GradCAM was used for CNN interpretation, and XGBoost models analyzed EVLP data and latent CNN features.