Regulatory strategies for early device development and approval.

The development of new technology to treat unmet clinical needs is an important component of modern cardiovascular disease. The need for this has been emphasized in the past several years beginning with the Food and Drug Administration (FDA) guidance document on Early Feasibility Studies in 2012 and then the 21st Century Cures legislation. A number of steps need to be considered in this process by the stakeholders involved including physician innovators and scientists, professional societies such as Society for Cardiovascular Angiography & Interventions, regulatory agencies, and medical device companies.

Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.

The development of technology to treat unmet clinical patient needs in the United States has been an important focus for the U.S. Food and Drug Administration and the 2016 Congressional 21st Century Cures Act.

Workflow efficiency for the treatment planning process in CT-guided high-dose-rate brachytherapy for cervical cancer.

Purpose: To investigate process efficiency, we present a prospective investigation of the treatment planning phase of image-guided brachytherapy (BT) for cervical cancer using a specific checklist.

Methods And Materials: From October 2012 to January 2014, 76 BT procedures were consecutively performed. Prospective data on the CT-based treatment planning process was collected using a specific checklist which details the following steps: (1) dosimetry planning, (2) physician review start, (3) physician review time, (4) dosimetry processing, (5) physics review start, (6) physics review, and (7) procedural pause.

Mycobacterium vaccae induces a population of pulmonary CD11c+ cells with regulatory potential in allergic mice.

The hygiene hypothesis proposes that common, harmless microorganisms, present throughout our evolutionary history, have helped to develop immunoregulatory mechanisms that prevent inappropriate immune responses by the host. Using a mouse model of allergic pulmonary inflammation, we report that treatment with an ubiquitous saprophytic mycobacterium, Mycobacterium vaccae, significantly reduces allergic inflammation by decreasing type 2 responses such as eosinophilia and IL-4 expression. Rather than observing an increase in type-1 cytokine expression, we found elevated production of IL-10 in the lungs suggesting a role for regulatory T cells.