Predicting airway immune responses and protection from immune parameters in blood following immunization in a pig influenza model.

Whereas the intranasally delivered influenza vaccines used in children affect transmission of influenza virus in the community as well as reducing illness, inactivated influenza vaccines administered by intramuscular injection do not prevent transmission and have a variable, sometimes low rate of vaccine effectiveness. Although mucosally administered vaccines have the potential to induce more protective immune response at the site of viral infection, quantitating such immune responses in large scale clinical trials and developing correlates of protection is challenging. Here we show that by using mathematical models immune responses measured in the blood after delivery of vaccine to the lungs by aerosol can predict immune responses in the respiratory tract in pigs.

Consideration of Cybersecurity Risks in the Benefit-Risk Analysis of Medical Devices: Scoping Review.

Background: The integration of connected medical devices (MDs) into health care brings benefits but also introduces new, often challenging-to-assess risks related to cybersecurity, which have the potential to harm patients. Current regulations in the European Union and the United States mandate the consideration of these risks in the benefit-risk analysis (BRA) required for MD approval. This important step in the approval process weighs all the defined benefits of a device with its anticipated risks to ensure that the product provides a positive argument for use.

Analysis of pulmonary complications and predicted postoperative pulmonary function in oncologic lung resections.

Background: Postoperative pulmonary complications (PPCs) represent a significant source of morbidity and mortality in surgical patients. Measurement of predicted postoperative forced expiratory volume in the first second (ppo FEV1) may allow for reliable prediction of PPCs and perioperative planning. This study aimed to determine if impaired ppo FEV1 is associated with increased risk of PPCs following oncologic lung resection.