REGULATORY APPROVAL OF NEW MEDICAL DEVICES: A CROSS SECTIONAL STUDY

Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature. Data sources PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. Eligibility criteria for study selection Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” Main outcome measures Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be “substantially equivalent” to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. Conclusions We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study

Studies on the expansion characteristics of the granular bed present in EGSB bioreactors

In this study, the expansion characteristics of an anaerobic granular bed in EGSB reactors based on terminal settling velocity study of the granules and the Richardson-Zaki equation (1954) have been investigated. The settling velocity study shows that the mean settling velocity of the granules is in accordance with the Allen formula because the settling process falls within the intermediate flow regime range (

Does environment affect the star formation histories of early-type galaxies?

Differences in the stellar populations of galaxies can be used to quantify the effect of environment on the star formation history. We target a sample of early-type galaxies from the Sloan Digital Sky Survey in two different environmental regimes: close pairs and a general sample where environment is measured by the mass of their host dark matter halo. We apply a blind source separation technique based on principal component analysis, from which we define two parameters that correlate, respectively, with the average stellar age (eta) and with the presence of recent star formation (zeta) from the spectral energy distribution of the galaxy. We find that environment leaves a second order imprint on the spectra, whereas local properties - such as internal velocity dispersion - obey a much stronger correlation with the stellar age distribution.Comment: 5 pages, 2 figures. Proceedings of JENAM 2010, Symposium 2: "Environment and the formation of galaxies: 30 years later

Internet of Things Enabled Technologies for Behaviour Analytics in Elderly Person Care: A Survey

The advances in sensor technology over recent years has provided new ways for researchers to monitor the elderly in uncontrolled environments. Sensors have become smaller, cheaper and can be worn on the body, potentially creating a network of sensors. Smart phones are also more common in the average household and can also provide some behavioural analysis due to the built in sensors. As a result of this, researchers are able to monitor behaviours in a more natural setting, which can lead to more useful data. This is important for those that may be suffering from mental illness as it allows for continuous, non-invasive monitoring in order to diagnose symptoms from different behaviours. However there are various challenges that need to be addressed ranging from issues with sensors to the involvement of human factors. It is vital that these challenges are taken into consideration along with the major behavioural symptoms that can appear in an Elderly Person. For a person suffering with Dementia, the application of sensor technologies can improve the quality of life of the person and also monitor the progress of the disease through behavioural analysis. This paper will consider the behaviours that can be associated with dementia and how these behaviours can be monitored through sensor technology. We will also provide an insight into some sensors and algorithms gathered through survey in order to provide advantages and disadvantages of these technologies as well as to present any challenges that may face future research

Patterning of ferroelectric nanodot arrays using a silicon nitride shadow mask

We grew well-ordered arrays of ferroelectric Pb (Zr0.2 Ti0.8) O3 (PZT) nanodots on a SrRu O3 SrTi O3 substrate by pulsed laser deposition. A silicon nitride shadow mask with ordered holes was used for patterning of the PZT arrays. Each dot has a height of ???15 nm and a diameter of ???120 nm with a similar dome shape over a large area. The ferroelectric properties of individual PZT dots were investigated by piezoresponse force microscopy. A single dot could be polarized individually and the polarized state remained unrelaxed to ???20 min.open232

Wave attenuation at a salt marsh margin: A case study of an exposed coast on the Yangtze estuary

To quantify wave attenuation by (introduced) Spartina alterniflora vegetation at an exposed macrotidal coast in the Yangtze Estuary, China, wave parameters and water depth were measured during 13 consecutive tides at nine locations ranging from 10 m seaward to 50 m landward of the low marsh edge. During this period, the incident wave height ranged from <0.1 to 1.5 m, the maximum of which is much higher than observed in other marsh areas around the world. Our measurements and calculations showed that the wave attenuation rate per unit distance was 1 to 2 magnitudes higher over the marsh than over an adjacent mudflat. Although the elevation gradient of the marsh margin was significantly higher than that of the adjacent mudflat, more than 80% of wave attenuation was ascribed to the presence of vegetation, suggesting that shoaling effects were of minor importance. On average, waves reaching the marsh were eliminated over a distance of similar to 80 m, although a marsh distance of >= 100 m was needed before the maximum height waves were fully attenuated during high tides. These attenuation distances were longer than those previously found in American salt marshes, mainly due to the macrotidal and exposed conditions at the present site. The ratio of water depth to plant height showed an inverse correlation with wave attenuation rate, indicating that plant height is a crucial factor determining the efficiency of wave attenuation. Consequently, the tall shoots of the introduced S. alterniflora makes this species much more efficient at attenuating waves than the shorter, native pioneer species in the Yangtze Estuary, and should therefore be considered as a factor in coastal management during the present era of sea-level rise and global change. We also found that wave attenuation across the salt marsh can be predicted using published models when a suitable coefficient is incorporated to account for drag, which varies in place and time due to differences in plant characteristics and abiotic conditions (i.e., bed gradient, initial water depth, and wave action).