FDA's role in expediting innovation of bioelectronic implants for vision restoration.

Bioelectronic implants for vision restoration are medical devices regulated in the United States by the Food and Drug Administration (FDA). This paper provides an overview of regulatory pathways and related FDA programs for bioelectronic implants for vision restoration, and identifies some of the gaps in the regulatory science of these devices. The FDA recognizes that additional discussion regarding development in this space is needed to further develop bioelectronic implants and ensure that safe and effective technologies are made available to patients with profound vision loss. FDA regularly participates in the Eye and the Chip World Research Congress meetings and continues to engage with important external stakeholders, including through public workshops such as the recent co-sponsored Expediting Innovation of Bioelectronic Implants for Vision Restoration. By participating in forums for discussion of these devices with all stakeholders, especially patients, FDA seeks to encourage advancement of these devices.

Reducing vehicle fuel consumption and exhaust emissions from the application of a green-safety device under real driving.

Vehicle emissions have a significantly negative impact on climate change, air quality and human health. Drivers of vehicles are the last major and often overlooked factor that determines vehicle performance. Eco-driving is a relatively low-cost and immediate measure to reduce fuel consumption and emissions significantly. This paper reports investigation of the effects of an on-board green-safety device on fuel consumption and emissions for both experienced and inexperienced drivers. A portable emissions measurement system (PEMS) was installed on a diesel light goods vehicle (LGV) to measure real-driving emissions (RDE), including total hydrocarbons (THC), CO CO2, NO, NO2 and particulate matter (PM). In addition, driving parameters (e.g. vehicle speed and acceleration) and environmental parameters (e.g. ambient temperature, humidity and pressure) were recorded in the experiments. The experimental results were evaluated using the Vehicle Specific Power (VSP) methodology to understand the effects of driving behavior on fuel consumption and emissions. The results indicated that driving behavior was improved for both experienced and inexperienced drivers after activation of the on-board green-safety device. In addition, the average time spent was shifted from higher to lower VSP modes by avoiding excessive speed, and aggressive accelerations and decelerations. For experienced drivers, the average fuel consumption and NO, NO2 and soot emissions were reduced by 5%, 56%, 39% and 35%, respectively, with the on-board green-safety device. For inexperienced drivers, the average reductions were 6%, 65%, 50% and 19%, respectively. Moreover, the long-term formed habits of experienced drivers are harder to be changed to accept the assistance of the green-safety device, whereas inexperienced drivers are likely to be more receptive to change and improve their driving behaviors.

Impact of drivers on real-driving fuel consumption and emissions performance.

Eco-driving has attracted great attention as a cost-effective and immediate measure to reduce fuel consumption significantly. Understanding the impact of driver behaviour on real driving emissions (RDE) is of great importance for developing effective eco-driving devices and training programs. Therefore, this study was conducted to investigate the performance of different drivers using a portable emission measurement system. In total, 30 drivers, including 15 novice and 15 experienced drivers, were recruited to drive the same diesel vehicle on the same route, to minimise the effect of uncontrollable real-world factors on the performance evaluation. The results show that novice drivers are less skilled or more aggressive than experienced drivers in using the accelerator pedal, leading to higher vehicle and engine speeds. As a result, fuel consumption rates of novice drivers vary in a slightly greater range than those of experienced drivers, with a marginally higher (2%) mean fuel consumption. Regarding pollutant emissions, CO and THC emissions of all drivers are well below the standard limits, while NOx and PM emissions of some drivers significantly exceed the limits. Compared with experienced drivers, novice drivers produce 17% and 29% higher mean NOx and PM emissions, respectively. Overall, the experimental results reject the hypothesis that driver experience has significant impacts on fuel consumption performance. The real differences lie in the individual drivers, as the worst performing drivers have significantly higher fuel consumption rates than other drivers, for both novice and experienced drivers. The findings suggest that adopting eco-driving skills could deliver significant reductions in fuel consumption and emissions simultaneously for the worst performing drivers, regardless of driving experience.

Large eddy simulation of vehicle emissions dispersion: Implications for on-road remote sensing measurements.

On-road remote sensing technology measures the concentration ratios of pollutants over CO2 in the exhaust plume in half a second when a vehicle passes by a measurement site, providing a rapid, non-intrusive and economic tool for vehicle emissions monitoring and control. A key assumption in such measurement is that the emission ratios are constant for a given plume. However, there is a lack of study on this assumption, whose validity could be affected by a number of factors, especially the engine operating conditions and turbulence. To guide the development of the next-generation remote sensing system, this study is conducted to investigate the effects of various factors on the emissions dispersion process in the vehicle near-wake region and their effects on remote sensing measurement. The emissions dispersion process is modelled using Large Eddy Simulation (LES). The studied factors include the height of the remote sensing beam, vehicle speed, acceleration and side wind. The results show that the measurable CO2 and NO exhaust plumes are relatively short at 30 km/h cruising speed, indicating that a large percentage of remote sensing readings within the measurement duration (0.5 s) are below the sensor detection limit which would distort the derived emission ratio. In addition, the valid measurement region of NO/CO2 emission ratio is even shorter than the measurable plume and is at the tailpipe height. The effect of vehicle speed (30-90 km/h) on the measurable plume length is insignificant. Under deceleration condition, the length of the valid NO/CO2 measurement region is shorter than under cruising and acceleration conditions. Side winds from the far-tailpipe direction have a significant effect on remote sensing measurements. The implications of these findings are discussed and possible solutions to improve the accuracy of remote sensing measurement are proposed.

Comparing Quality of Life in Breast Cancer Patients Who Underwent Mastectomy Versus Breast-Conserving Surgery: A Meta-Analysis.

: The purpose of our study was to carry out a meta-analysis of current literature to determine whether total mastectomy and breast-conserving surgery induce different outcomes in quality of life, based on the breast-cancer-specific module of the European Organizaation for Research and Treatment of Cancer core questionnaire (EORTC QLQ-BR23) used postoperatively. A systematic literature search of PubMed and EMBASE was conducted. Observational clinical studies that compared the quality of life in different surgery groups and presented empirical findings were selected. Six studies met the inclusion criteria. Breast-conserving surgery has statistically significant better outcomes than mastectomy in three of the eight outcomes measured in the EORTC QLQ-BR23, namely body image (standard mean difference, SMD = 1.742, 95% CI 0.579-2.905, p = 0.003), future perspective (SMD = 0.606, 95% CI 0.075-1.138, p = 0.025) and systemic therapy side effects (SMD = -0.641, 95% CI 0.101-1.181, p = 0.020). Our study highlighted that breast-conserving surgery was preferred over mastectomy because breast-conserving surgery leads to better outcomes in body image, future perspectives and less systemic side effects.