SpineGuard said it landed Japanese Ninsho approval for its PediGuard, a handheld surgical product that helps guide proper spine screw placement. Paris- and San Francisco-based SpineGuard is touting it as regulatory win in the world's 2nd-largest spine market, after the U.S., according to a release.
PLC Systems said its RenalGuard device was used in a new clinical trial evaluating the device in treating patients with acute kidney failure undergoing transcatheter aortic valve implantation. The TAVI procedure, used in patients with faulty aortic valves, can cause complications including acute kidney failure.
Fraunhofer FIT demonstrates a mobile wireless system that monitors the health of elderly people in their own homes, using miniature sensors, and also a novel optical system for detecting antibiotic resistance, which can determine in just two hours if bacteria react to a specific antibiotic.
The National Institutes of Health has awarded Georgia Tech a $2-million research grant to unravel the mechanical forces at play in lymphedema, a poorly understood disease with no cure and little hope for sufferers. Lymphedema develops when the body fails to circulate lymphatic fluid, a mixture of immune cells, proteins, and lipids.
Regentis Biomaterials announced today new clinical data demonstrating the efficacy and safety of its GelrinC implant for treating articular cartilage in injured knees. As presented at the International Cartilage Repair Society World Congress in Izmir, Turkey, the clinical results demonstrated sustained knee function improvement over 24 months after implantation and significant pain reduction.
Neuros Medical, Inc., a medical device company announced it has received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration for their implantable generator. The device, named Altius™, delivers patented high frequency Electrical Nerve Block™ technology for patients suffering from chronic pain.
The study found that minimally invasive surgery for prostate cancer, including laparoscopic and robotic-assisted surgery, was associated with lower transfusion rates, shorter length of hospital stay, and lower serious postoperative complication and mortality rates compared to open prostatectomy.
Spinal injuries are present in 1 out of 9 U.S. military personnel sustaining combat injuries in Iraq or Afghanistan -- a much higher rate than in previous wars, according to a report in the Sept. 15 issue of Spine. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.
Andrew Fish, executive director of AdvaMedDx, a division of the Advanced Medical Technology Association (AdvaMed) focused on diagnostics policy matters, released the following statement on the introduction in the U.S. House of Representatives of the Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act.
Just as wires must be insulated to effectively carry electrical impulses, nerve cells must be insulated by myelin to effectively transmit neural impulses. Using typical magnetic resonance imaging or MRI, one can visually distinguish parts of the brain that look white and parts that look gray.
A team from the Universities of Leicester and Birmingham found that the secondary use of data from an electronic prescribing and decision support system in an English hospital led to a ‘substantial and sustained’ reduction in rates of missed or delayed doses of medicines.
A new EU project, METSY, develops and applies neuroimaging and bioinformatics tools to study how lipid metabolism is connected to psychotic disorders and metabolic co-morbidities such as metabolic syndrome and diabetes. The overall objective is to identify, prioritize and evaluate multi-modal blood and neuroimaging biomarkers...
Corindus Vascular Robotics, a leading developer of precision vascular robotics, today announced the PRECISION Registry, an ongoing study aimed at collecting data on the patterns of use, safety and effectiveness in the delivery and manipulation of percutaneous coronary intervention (PCI) devices.
Quidel Receives Two FDA Clearances for Molecular Diagnostic Tests for Use on Life Technologies QuantStudio(TM) DxSeptember 16, 2013 8:00 am | by The Associated Press | News | Comments
Quidel Corporation and Life Technologies Corporation announced today that the United States Food and Drug Administration (FDA) has granted 510(k) clearances to the Quidel Molecular Influenza A+B assay and the Quidel Molecular RSV + hMPV assay, both for use on the QuantStudio Dx Real-Time PCR Instrument by Life Technologies.
While all electronic products must comply with electromagnetic compatibility (EMC) requirements, EMC evaluation of medical devices is expanded to include product safety. This step-up is understandable as human health and life are frequently dependent on medical devices in a healthcare setting.