The Biozoom scanner non-invasively measures and analyzes the biomarkers critical to understanding, managing, and improving a user's health and wellness. The prototype units have been validated in clinical trials and used at respected European institutions. The first commercially produced scanners are expected to arrive in September.
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
When designing a medical device that is meant to be used directly by patients in their home, the designer has to keep in mind that the environment of a patient’s home is likely going to be dramatically different compared to a medical facility.
Various areas of the brain process our sensory experiences. How the areas of the cerebral cortex communicate with each other and process sensory information has long puzzled neuroscientists. Exploring the sense of touch in mice, brain researchers from the University of Zurich demonstrate that the transmission of sensory information from one cortical area to connected areas depends on the task to solve and the goal-directed behavior.
What if experts could dig into the brain, like archaeologists, and uncover the history of past experiences? This ability might reveal what makes each of us a unique individual, and it could enable the objective diagnosis of a wide range of neuropsychological diseases.
Bacterial DNA may integrate into the human genome more readily in tumors than in normal human tissue, scientists have found. The researchers, affiliated with the University of Maryland School of Medicine's Institute for Genome Sciences, analyzed genomic sequencing data available from the Human Genome Project, the 1,000 Genomes Project and The Cancer Genome Atlas.
Japanese researchers have developed a new sugar and water-based solution that turns tissues transparent in just three days, without disrupting the shape and chemical nature of the samples. Combined with fluorescence microscopy, this technique enabled them to obtain detailed images of a mouse brain at an unprecedented resolution.
Medical electronic devices are no longer a trend; they are the reality of today’s healthcare environment. Seemingly, the number of powered medical devices far exceeds their non-powered counterparts. Even devices that had traditionally not been powered, such as the stethoscope, are now either being replaced by more effective electronic devices or being updated with electronics to function more efficiently and, more simply, better.
Concord Medical Services Holdings Limited, a leading specialty hospital management solution provider, operator of the largest network of radiotherapy and diagnostic imaging centers in China and the parent of Chang'an Hospital, today reported that it has launched DoctorInPocket or Zhang Shang Hao Yi, in Chinese, a mobile health application.
Imagine a swarm of tiny devices only a few hundred nanometers in size that can detect trace amounts of toxins in a water supply or the very earliest signs of cancer in the blood. Now imagine that these tiny sensors can reset themselves, allowing for repeated use over time inside a body of water – or a human body.
An NJIT research professor known for his cutting-edge work with carbon nanotubes is overseeing the manufacture of a prototype lab-on-a-chip that would someday enable a physician to detect disease or virus from just one drop of liquid, including blood.
A new study reports that the use of a quarterly report card is associated with improved colonoscopy quality indicators. Endoscopists at the Roudebush Veterans Affairs Medical Center in Indianapolis, Ind., who participated in the study showed an overall adjusted adenoma (precancerous polyp) detection rate increase from 44.7 percent to 53.9 percent, and a cecal intubation rate increase from 95.6 percent to 98.1 percent.
Design and development of a medical device is an exacting process, to say the least, and it assumes even more complexity because it almost always extends across years that encompass multiple iterations of the device. As a result, small things that were satisfactory in the prototype and first production run can grow to be problems that must be solved as production volume rises.
The conference program for MEDICA 2013, International Trade Fair with Congress – World Forum for Medicine, is undergoing a full re-launch. The content repositioning for MEDICA 2013 (to be held from November 20 – 23, 2103 in Düsseldorf, Germany) is designed to closely fit the program of the trade fair’s topics relevant to medical equipment users and to expand the international side of the program.
Neuroscientists may soon be modern-day harpooners, snaring individual brain-cell signals instead of whales with tiny spears made of carbon nanotubes. The new brain cell spear is a millimeter long, only a few nanometers wide and harnesses the superior electromechanical properties of carbon nanotubes to capture electrical signals from individual neurons.
Duke University biomedical engineers and genome researchers have developed a proof-of-principle approach using light to detect infections before patients show symptoms. The approach was demonstrated in human samples, and researchers are now developing the technique for placement on a chip, which could provide fast, simple and reliable information about a patient.
A landmark three-dimensional (3-D) digital reconstruction of a complete human brain, called the BigBrain, now for the first time shows the brain anatomy in microscopic detail—at a spatial resolution of 20 microns, smaller than the size of one fine strand of hair—exceeding that of existing reference brains presently in the public domain.
Lumosity, the leading brain training company, today announced a new web-based, big data methodology for conducting human cognitive performance research. Lumosity's research platform, the Human Cognition Project, contains the world's largest and continuously growing dataset of human cognitive performance, which currently includes more than 40 million people who have been tracked for up to 6 years.
A more accurate and reliable stroke prediction model has been developed to help physicians decide whether to start blood-thinning treatment for patients with atrial fibrillation, as described in the current online issue of the Journal of the American Heart Association.
A team of NUS researchers from the Departments of Bioengineering and Orthopaedic Surgery has developed a highly realistic three-dimensional (3D) tumour model. As it replicates the conditions in the body, it is able to track the effectiveness and progress of drug therapy.
Techne, which makes medical testing and diagnostic products, said Tuesday that it reached a deal to buy Bionostics Holdings Ltd. and its operating subsidiary Bionostics Inc. for $104 million in cash.
Researchers in the University’s Physics and Pharmacy & Pharmacology Departments are using a pioneering technique to study the properties and characteristics of our skin, in tests that could pave the way for new treatments for dermatitis, and for an improved understanding of the skin ageing process.
Out in the wilds or anywhere off the grid, sophisticated instruments small enough to fit in a shirt pocket will one day scavenge power from sunlight, body heat, or other sources to monitor water quality or bridge safety or function as wearable biomedical monitors, enabling analysis in the field rather than bringing samples and data back to the lab.
A medical test previously developed to measure a toxin found in tobacco smokers has been adapted to measure the same toxin in people suffering from spinal cord injuries and multiple sclerosis, offering a potential tool to reduce symptoms.
The Supreme Court ruled Thursday that companies cannot patent parts of naturally-occurring human genes, a decision with the potential to profoundly affect the emerging and lucrative medical and biotechnology industries. The high court's unanimous judgment reverses three decades of patent awards by government officials.