Alere Connect has been granted a 510(k) market clearance by the U.S. FDA for the Alere MobileLink. The new product offering is one of Alere's connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems accessed by their healthcare providers.
Reaching a clinic in time to receive an early diagnosis for cancer -- when the disease is most treatable -- is a global problem. And now a team of Chinese researchers proposes a global solution: have a user-friendly diagnostic device travel to the patient, anywhere in the world.
A novel interactive 3Dimensional (3D) simulation platform offers surgical residents a unique opportunity to hone their diagnostic and patient management skills, and then have those skills accurately evaluated according to a new study appearing in the August issue of the Journal of the American College of Surgeons.
FDA Clears Hologic's Single Energy Femur Exam to Visualize Features Associated with Developing Atypical Femur Fractures on a DXA PlatformAugust 1, 2013 4:07 pm | by PR Newswire | News | Comments
Hologic announced it received U.S. Food and Drug Administration (FDA) clearance for the Company's Single Energy (SE) Femur Exam on a dual energy x-ray absorptiometry (DXA) platform for the assessment of features associated with atypical femur fractures (AFF).
Physicists and neuroscientists from The University of Nottingham and University of Birmingham have unlocked one of the mysteries of the human brain, thanks to new research using functional Magnetic Resonance Imaging (fMRI) and electroencephalography (EEG).
MIT researchers have developed a new endoscopy technology that could make it easier for doctors to detect precancerous lesions in the colon. Early detection of such lesions has been shown to reduce death rates from colorectal cancer, which kills about 50,000 people per year in the United States.
The handheld biosensor was developed by researchers at the University of Illinois, Urbana-Champaign. A series of lenses and filters in the cradle mirror those found in larger, more expensive laboratory devices. Together, the cradle and app transform a smartphone into a tool that can detect toxins and bacteria, spot water contamination and identify allergens in food.
Afraid there may be peanuts or other allergens hiding in that cookie? Thanks to a cradle and app that turn your smartphone into a handheld biosensor, you may soon be able to run on-the-spot tests for food safety, environmental toxins, medical diagnostics and more.
According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, patient and hospital demand for minimally invasive and discreet devices is rising within European markets for urological devices, and products that meet these needs are poised to see strong adoption through 2021.
Tiny silicon crystals caused no health problems in monkeys three months after large doses were injected, marking a step forward in the quest to bring such materials into clinics as biomedical imaging agents, according to a new study. The findings suggest that the silicon nanocrystals, known as quantum dots, may be a safe tool for diagnostic imaging in humans.
Chemists at Johannes Gutenberg University Mainz (JGU) have developed a new method for parallel protein analysis that is, in principle, capable of identifying hundreds or even thousands of different proteins. It could be used to detect the presence of viruses and identify their type in tiny samples.
Taking advantage of the sensitive nature of randomly scattered light, Yale University researchers have developed an ultra-compact, low-cost spectrometer with improved resolution over existing micro models. The innovation represents an advance in “lab-on-a-chip” technology, or the consolidation of laboratory capabilities in miniature, highly portable devices.
Engineers at the California Institute of Technology (Caltech) have devised a method to convert a relatively inexpensive conventional microscope into a billion-pixel imaging system that significantly outperforms the best available standard microscope.
GE Healthcare Submits the Final Module of Its Premarket Approval Application (PMA) for GE Breast Tomosynthesis OptionJuly 30, 2013 9:00 am | by Business Wire | News | Comments
GE Healthcare, a unit of General Electric Company (NYSE:GE), announced that it recently submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval application (PMA1) for GE Breast Tomosynthesis, an option of the Senographe Essential system.
Polymer Technology Systems, Inc. (PTS, Inc.), the U.S.-based manufacturer of the CardioChek family of point-of-care diagnostic products, introduced the CardioChek Plus analyzer today at the annual American Association for Clinical Chemistry (AACC) in Houston.
IntelligentMDx (privately held) announced today that the U.S. Food and Drug Administration (FDA) has cleared its automated molecular diagnostic test that detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE).
The University of Salford has carried out a systematic review of the literature to research the effectiveness of telehealth on clinical outcomes, cost effectiveness and patient experience. Telehealth allows patients to monitor long-term health conditions from home, reducing visits to a clinic or hospital.
Today’s medical staffs increasingly rely upon wireless networks and devices to conduct critical-care applications, access electronic medical records and test results, and to share information throughout facilities. At the same time, Wi-Fi networks in healthcare facilities are being pushed to the limits by the Bring Your Own Device (BYOD) trend among patients and guests.
Modern genomics has shown that just one mutation can be the difference between successfully treating a disease and having it spread rampantly throughout the body. Now, researchers have developed a new method that can look at a specific segment of DNA and pinpoint a single mutation, which could help diagnose and treat diseases such as cancer and tuberculosis.
Trovagene, Inc. (NASDAQ: TROV) and RainDance Technologies announced today that Trovagene has adopted RainDance's RainDropTM Digital PCR System for research and development, and for eventual use in the Trovagene CLIA laboratory. Trovagene has also announced successful development of a cell-free DNA mutation assay leveraging the RainDrop platform.
Cepheid has announced that it has received market authorization from the U.S. Food & Drug Administration (FDA) for its Xpert MTB/RIF test. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be down-classified and brought to market.
Cepheid today announced it has received market authorization from the U.S. Food & Drug Administration (FDA) for its Xpert MTB/RIF test. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be down-classified and brought to market.
Study in British Journal of Urology International Features a Practical Solution for MRI-Ultrasound Fusion to Enable Tumor-Targeted, Tissue-Preserving Prostate HIFU TreatmentJuly 25, 2013 2:16 pm | by The Associated Press | News | Comments
Study results published in the current issue of British Journal of Urology International (10.1111/bju.12223) demonstrate that new software to register and fuse information from magnetic resonance imaging (MRI) and ultrasound (US) images enables intraoperative visualization of tumors, not ordinarily seen in a US image.
Over 85 percent of all pancreatic cancers are diagnosed late, when someone has less than two percent chance of survival. How could this be? Jack Andraka talks about how he developed a promising early detection test for pancreatic cancer that’s super cheap, effective and non-invasive -- all before his 16th birthday.
Diagnosing the presence of Yersinia pestis, the cause of plague, may soon be easier than ever before. Scientists working with Peter Seeberger, Director at the Max Planck Institute of Colloids and Interfaces (MPIKG) in Potsdam and Professor at the Freie Universität Berlin, have come up with a simple, inexpensive and reliable method of detecting the bacterium.