A new technique may help clinicians hone in on a diagnosis in patients presenting with a pleural effusion of unknown cause. The study, led by principal investigator Y.C. Gary Lee, Ph.D., appears in the September 1 issue of the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.
New General Tumor Marker Test Now Available
GenWay Clinical Laboratory, a US-based diagnostic company with CLIA certification, has validated a general tumor marker test in their laboratory and now offers this testing service. This is an ELISA-based assay which simply requires a small blood sample from the patient in order to quantify the amount of the tumor marker in their serum.
Epocal Announces FDA Clearance Of Glucose Test
Epocal, Inc., a leading edge provider of point of care technology, announced that it has received U.S. Food and Drug Administration (FDA) clearance to market its new glucose test on the epoc Blood Analysis System. Glucose measurements are used for the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell tumors.
Wearable Kidney May Replace Dialysis Machine
Researchers are developing a Wearable Artificial Kidney for dialysis patients, reports an upcoming paper in the Clinical Journal of the American Society of Nephrology (CJASN). “Our vision of a technological breakthrough has materialized in the form of a Wearable Artificial Kidney, which provides continuous dialysis 24 hours a day, seven days a week,” comments Victor Gura, MD (David Geffen School of Medicine at UCLA).
FDA Proposes Mandatory Electronic Safety Reporting
The U.S. Food and Drug Administration is proposing to amend postmarket safety reporting regulations for three of its centers to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format. The agency issued two proposed rules today-one that applies to electronic medical device adverse event reporting and one that applies to electronic drug and biologic product adverse experience reporting.
Featured Clinical Trials To Be Presented At Transcatheter Cardiovascular Therapeutics 2009 In San Francisco
Special presentations will be made Sept. 24, 2-6 p.m. WHAT: A series of Featured Clinical Trials will be presented at Transcatheter Cardiovascular Therapeutics (TCT), in addition to late-breaking clinical trials. These featured clinical trials represent groundbreaking research and will yield data and insight that will further the field of interventional cardiology. WHEN: The TCT Featured Clinical Trials will be presented on September 24, 2009 from 2:00 – 6:00 pm.
STAAR Surgical Reports Progress On Japanese Application For Approval Of Visian(TM) Implantable Collamer(R) Lens (ICL(TM))
STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, reported on the status of its application to obtain approval to market the Company’s Visian ICL products in Japan. As anticipated, the Ministry of Health, Labour and Welfare’s Expert Meeting II was held at the end of July in Japan, at which time the STAAR Visian ICL products were considered for approval in the Japanese market.
FDA Advisory Committee Recommends Datscan™ (Ioflupane I 123 Injection)
GE Healthcare announced that the Peripheral and Central Nervous System Drugs advisory committee of the U.S. Food and Drug Administration (FDA) has voted to recommend DaTSCAN™ (Ioflupane I 123 Injection) to the FDA. The panel determined DaTSCAN has a favorable risk to benefit profile, voting 11 to two with one abstention.
$4M Funding From The NIBIB To Support The Center For Synchrotron Biosciences
The Case Western Reserve University School of Medicine has received a $4 million grant from the National Institute of Biomedical Imaging and Bioengineering, a division of the National Institutes of Health (NIH), to fund the Case Center for Synchrotron Biosciences. The center, to be funded through 2014, provides resources for the NIH funded scientific community to support the study of the structure and dynamics of proteins and nucleic acids.
Researchers Develop Faster And Cheaper Way To Find Disease Genes
A faster and cheaper way to find disease genes in the human genome that is being developed by researchers in the US has passed its initial “proof of concept” test by finding previously unknown gene mutations for Freeman-Sheldon syndrome, a rare Mendelian disorder, in unrelated affected individuals. Researchers from the University of Washington (UW) in Seattle wrote about their work in a paper that appears in the 16 August issue of Nature.
Mums-to-be Warned Over Use Of Fetal Heart Rate Monitors
Mums-to-be are being advised not to use personal monitors (Doppler devices) to listen to their baby’s heartbeat at home over fears that they may lead to delays in seeking help for reduced fetal movements. In this week’s BMJ, Dr Thomas Aust and colleagues from the Department of Obstetrics and Gynaecology at Arrowe Park Hospital, Wirral describe the case of a 27 year old woman who presented to their labour ward 32 weeks into her first pregnancy with reduced fetal movements.