The gold standard for almost all the paper based diagnostic tests is the home pregnancy test called Clear Blue. What is forgotten is that this test was created in 1985 by a company called Unipath and this went on to become the most often used test that became a standard by which most diagnostic tests…
Food and Drug Administration (FDA) regulates significant portion of medically relevant devices and drugs but it is probably not as well known that they also regulate the software that is used to power many of the studies. There are significant guidelines from FDA that are used for manufacturers of software that regulate medical devices. The…
Computers are good with numbers and can form precise calculations. They remember perfectly and can manage big lists of numbers. What they are not good at is averaging and understanding meaning. So for example, “St Peters Hospital” will be different from “St Peter’s Hospital” if it appears in medical records. And, nowadays since most of…
Robert Prance’s team at University of Sussex in UK have discovered and created a unique electric potential sensor that is a perfect voltmeter and can measure a heart beat from nearly 3 feet away. It measures the spatial electrical potential or field. This has been difficult since the electrometers that measure voltage, electric charge or…
The measurement of muscle contraction is important for various disorders in the muscular and neuronal system. Muscles get the input to contract from a brain through the neuron at a specific junction. This is accomplished through a generation of an electrical pulse in millivolts (20-30mV) oscillating at a frequency of 7-20Hz. The measurement of this…
The understanding and measurement of the brain is accomplished by various means. EEG (Electroencephalogram), Computerized Axial tomography, Positron Emission tomography, Magnetic resonance imaging and Magnetoencephalography. EEG was among the first measurements undertaken to understand the working of the brain. It is a summation of the electrical activity of the brain. The audio analogy to understanding…
Conversions get very confusing easily, especially when the standards are defined differently for different items and are also different across countries. It is important to understand what do the terms mean for a medical device manufacturer. Here are the basics: The standard Standards are below and they are all linear simple formulas to correlate with…
Food and Drug Administration (FDA) regulates significant portion of medically relevant devices and drugs but it is probably not as well known that they also regulate the software that is used to power many of the studies. There are significant guidelines from FDA that are used for manufacturers of software that regulate medical devices. The…
FDA has been working to release a rule that will require that each medical device be uniquely identified by an identification number and bar code. This will enable each device to be targeted in case there are any issues at a later point. This requires that as the medical devices are made, they need to…
Electrochemical assays have typically suffered from poor sensitivity compared to optical technology. In addition, they sometimes have a large background signal which makes detection of analyte difficult. However, the ability to detect the analyte in turbid or complex signal is the holy grail that is usually very difficult with optical methods. Many laboratories have struggled…
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