Guided Therapeutics Continues to Await Update from FDA on Its PMA Application for LuViva® Advanced Cervical ScanJuly 3, 2013 8:06 am | by Business Wire | News | Comments
Guided Therapeutics commented on the status of its Pre-market Approval application for the LuViva Advanced Cervical Scan. While the Company requested a phone meeting with the FDA after the passing of their 180 day internal guidance and did speak with the agency, the company was informed that LuViva remains under FDA review.
To unlock the potential of more frequent therapy, medical devices must move out of the doctor’s office and travel with patients to their homes and offices. But, this great opportunity is not without its challenges. The same patient who stands to reap great benefit from a home medical device may instead endanger themselves by applying the device incorrectly.
Guided Therapeutics and I.T.E.M. Medical Technologies Group Announce Turkish Ministry of Health Sponsored Cervical Cancer Prevention Program Involving the LuViva® Advanced Cervical ScanJuly 2, 2013 8:29 am | by Business Wire | News | Comments
NORCROSS, Ga. & ANKARA, Turkey--(BUSINESS WIRE)--Jul 2, 2013--First graph, second sentence should read: The program for 2013 and 2014, to be funded by Turkey’s Ministry of Health (sted The program for 2013 and 2104). The corrected release reads: GUIDED THERAPEUTICS AND...
University Hospitals Case Medical Center and Case Western Reserve University Announce Licensing Agreement for the Development of Diagnostic Tests for HIV Drug ResistanceJuly 2, 2013 6:00 am | by The Associated Press | News | Comments
Case Western Reserve University has signed an exclusive worldwide licensing agreement granting University Hospitals (UH) Case Medical Center rights to a series of diagnostic tests to determine drug resistance and co-receptor tropism in human immunodeficiency virus (HIV). The phenotypic and...
As Parker sees it, the three biggest obstacles to [design] success for patient care products, such as oxygen concentrators and ventilators, are portability, battery life, and reliability. To make home care products more portable, Parker has reduced the size of some valves up to 75%.
DNA fragments in your blood may someday help doctors quickly learn if chest pain means you have narrowed heart arteries, according to a new study published in the American Heart Association journal Arteriosclerosis, Thrombosis, and Vascular Biology.
Veracyte, Inc., a molecular diagnostics company in the field of molecular cytology, today announced the completion of the final tranche of its $28 million Series C financing. The financing included GE Ventures as a new investor, as well as existing investors Domain Associates, Kleiner Perkins Caufield & Byers, TPG Biotech, and Versant Ventures.
A new method, which analyzes the sounds in a child's cough, could soon be used in poor, remote regions to diagnose childhood pneumonia reliably. According to Udantha Abeyratne from the University of Queensland in Australia and colleagues, this simple technique of recording coughs with a microphone on the patient's bedside table, has the potential to revolutionize the management of childhood pneumonia in remote regions around the world.
Engineers from Queen Mary, University of London have developed the most precise computer simulation of how red blood cells might travel around the body to help doctors treat people with serious circulatory problems. Understanding how damaged red blood cells might interact with each other or their neighboring cells could be useful in realizing blood flow in patients who are diabetic or have had surgery to address circulation complications.
In the latest issue of Neuron, a team led by Gladstone Investigator Anatol Kreitzer, PhD, and Salk Investigator Edward Callaway, PhD, combined mouse models with a sophisticated tracing technique—known as the monosynaptic rabies virus system—to assemble brain-wide maps of neurons that connect with the basal ganglia, a region of the brain that is involved in movement and decision-making.
Lens-Free Imaging Technique Dramatically Extends Research Capabilities into Cells, Bacteria, and VirusesJune 27, 2013 12:48 pm | by Business Wire | News | Comments
CEA-Leti today introduced a new video lens-free imaging technique that redefines bio imaging, provides significant advantages over traditional microscopy, and opens a new range of capabilities for researchers, such as real-time monitoring of cell cultures.
When a breast tumor is detected, many women opt to have a lumpectomy, which is surgery designed to remove the diseased tissue while preserving the breast. But during this procedure, doctors cannot learn right away whether all of the cancerous tissue has been removed, with no microscopic signs that cancer cells were left behind.
To reduce the need for second surgeries, four Johns Hopkins graduate students have designed a device to allow pathologists to quickly inspect excised breast tissue within 20 minutes, while the patient is still in the operating room. If this inspection indicates that the tumor was not fully removed, additional tissue can then be removed during the same operation.
On this episode of The Pulse, a major step toward an artificial pancreas, detecting disease from just one drop blood, creating mature human cardiac patches from human heart cells, and a smart sock that helps runners improve their technique and prevent injuries.
The antibacterial effects of silver are well established. Now, researchers at Yonsei University in Seoul, Republic of Korea, have developed a technique to coat glass with a layer of silver ions that can prevent growth of pathogenic bacteria including Escherichia coli, Salmonella typhimurium and Campylobacter jejuni. The technology could be used to protect medical equipment.
Our present understanding of thermodynamics is fundamentally incorrect if applied to small systems and needs to be modified, according to new research from University College London (UCL) and the University of Gdańsk. The findings, published today in Nature Communications, have wide applications in small systems, such as biological motors and systems found in the body.
With the 3rd Edition of IEC 60601-1 impacting U.S. design engineers in June, it is critical they are aware of the implications to their medical device designs. For home healthcare devices, there is a collateral standard that will have a specific effect. This article focuses in on powering these products and the items in the standard of significance for that aspect.
Padilla and researchers in his lab recently reported a breakthrough in efforts to create accessible and effective THz imaging. Using both optical and electronic controls, the team developed a single-pixel imaging technique that uses a coded aperture to quickly and efficiently manipulate stubborn THz waves, according to a recent report in the journal Optics Express.
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.