Real-world data to support post-market safety and performance of embolization coils: evidence generation from a medical device manufacturer and data institute partnership.

Background: Recognizing the limitations of pre-market clinical data, regulatory authorities have embraced total product lifecycle management with post-market surveillance (PMS) data to assess medical device safety and performance. One method of proactive PMS involves the analysis of real-world data (RWD) through retrospective review of electronic health records (EHR). Because EHRs are patient-centered and focused on providing tools that clinicians use to determine care rather than collecting information on individual medical products, the process of transforming RWD into real-world evidence (RWE) can be laborious, particularly for medical devices with broad clinical use and extended clinical follow-up.

Buoyant ascent rate profiles for the MK10 and MK11 submarine escape and immersion equipment.

Introduction: Since the U.S. Navy transitioned from the MK10 to the MK11 submarine escape and immersion equipment (SEIE), there has been an increase in the incident rate of pulmonary barotrauma during submarine escape training.

Real-world performance of SARS-Cov-2 serology tests in the United States, 2020.

Background: Real-world performance of COVID-19 diagnostic tests under Emergency Use Authorization (EUA) must be assessed. We describe overall trends in the performance of serology tests in the context of real-world implementation.

Methods: Six health systems estimated the odds of seropositivity and positive percent agreement (PPA) of serology test among people with confirmed SARS-CoV-2 infection by molecular test.

Minimum lymph node yield in elective level I-III neck dissection.

Objectives/hypothesis: Unlike lymphadenectomy at other sites, there is no discrete lymph node count defining an adequate neck dissection. The purpose of this study was to determine the minimum lymph node yield (LNY) of an elective level I-III neck dissection required to reliably capture any positive nodes present in these nodal basins.

Study Design: Retrospective single-institution analysis.

Two putative histidine kinases are required for cyst formation in Rhodospirillum Centenum.

The photosynthetic bacterium, Rhodospirillum centenum, has a flexible life cycle that permits it to survive starvation as dormant cyst cells. Previous studies have identified some of the key regulators for encystment and demonstrated that the control of development is intricate. This complexity may arise from the need to integrate several environmental signals to mediate a switch from one mode of energy metabolism to another and to ensure that a transition to dormancy is initiated only when necessary.