The US Food and Drug Administration (FDA) has cleared Toshiba America Medical Systems' new Vantage Titan 1.5T line. Vantage Titan 1.5T line, which features the 8-, 16- and 32-channel MR systems, comprises a 71 cm bore, Toshiba's ...
Tags: FDA, medical device, clinical technology
The US Food and Drug Administration (FDA) has proposed a rule to develop a new unique device identification (UDI) system in response to legislation passed by Congress in June 2012. The FDA has worked closely with industry, the clinical ...
The US Food and Drug Administration (FDA) has cleared 510(k) pre-marketing notification application (PMA) of ETView Medical's Viva EB Endobronchial blocker. Viva EB comprises a sterile, single-use, steerable, balloon tipped catheter ...
Tags: FDA, Viva EB, Endobronchial blocker, medical device
Derma Sciences has acquired exclusive rights of Quick-Med Technologies' intellectual property related to the Nimbus antimicrobial technology, available in Bioguard dressings. The FDA cleared Nimbus is a non-toxic, long-lasting ...
Tags: Derma Sciences, Quick-Med Technologies, Nimbus antimicrobial technology
The US Food and Drug Administration (FDA) has cleared Toshiba America Medical Systems' new 16-detector row Aquilion RXL Edition CT system. The Aquilion RXL system includes Toshiba's Adaptive Iterative Dose Reduction 3D (AIDR 3D) ...
Tags: FDA, medical device, medical technology
Abiomed has received US Food and Drug Administration's (FDA) investigational device exemption (IDE) to begin a pivotal clinical study of its Impella Right-side Percutaneous (RP ) pump. The percutaneous heart pump is implanted through a ...
Tags: percutaneous heart pump, Impella Right-side Percutaneous pump, FDA
The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to STENTYS to conduct a pivotal APPOSITION V clinical study for its Self-Apposing stent. The Self-Apposing technology, which adapts vessels with ...
The US Food and Drug Administration (FDA) has approved an expanded indication for use of Integra LifeSciences' Vu aPOD Prime intervertebral body fusion device (IBD) in anterior lumbar interbody fusion (ALIF) procedures. The Vu aPOD Prime ...
Tags: intervertebral body fusion device, supplemental fixation implants
ParadigmSpine has obtained premarket approval (PMA) for its motion preserving interlaminar stabilization device from the US Food and Drug Administration (FDA). The minimally invasive coflex device is designed for treating moderate to ...
CardioComm Solutions has signed a three year enterprise cloud services (ECS) agreement with SunGard Availability Services, a subsidiary of SunGard Data Systems. The ECS agreement will provide CardioComm with the systems infrastructure to ...
To address safety concerns about the expression of drug strength on labels for heparin sodium injections and heparin lock flush solutions, the U.S. Pharmacopeial Convention (USP) has revised its current standards for these products. Heparin ...
The US Food and Drug Administration (FDA) has granted 510(K) approval to Cytomedix to use its Angel Concentrated Platelet Rich Plasma (cPRP) system to process a small sample of blood or a mixture of blood and bone marrow aspirate. ...
Auxogyn has obtained CE mark approval for its non-invasive early embryo viability assessment (Eeva) test, designed to improve in vitro fertilization (IVF) outcomes. By using intelligent computer vision software, Eeva test measures ...
SciBase has announced positive results of its non-invasive point-of-care Nevisense device from the pivotal SIMPS study. The patented Nevisense device, which includes an electrode on a hand-held probe, utilizes electrical impedance ...
Tags: SciBase, Nevisense device, electrical impedance spectroscopy
The US Food and Drug Administration (FDA) has approved Roche's automated Elecsys Vitamin D assay for use on cobas modular analyzer platforms. The Elecsys Vitamin D assay, which measures both vitamin D2 and D3 levels, provides results ...
Tags: FDA, Elecsys Vitamin D assay