Edwards Lifesciences is set to begin clinical trial to assess its Intuity valve system, following an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA). The prospective, multi-center study, ...
Tags: clinical trial, Intuity valve system, FDA
The US Food and Drug Administration (FDA) has granted approval to Pulmonx to commence an investigational device exemption (IDE) pivotal clinical study of its Zephyr Endobronchial Valve (EBV) therapy, designed to treat emphysema. The ...
Tags: FDA, Endobronchial Valve therapy, emphysema, Zephyr EBV therapy
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
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 ...
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. ...
SinuSys has obtained CE mark for its AerOs Sinus Dilation system, designed to open the maxillary ostia (openings that connect a sinus to the nasal cavity) and treat painful chronic sinusitis. The low pressure, self-expanding AerOs device ...
Tags: SinuSys, AerOs System, sinus disease
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
The US Food and Drug Administration (FDA) has approved Roche's new COBAS TaqMan HIV-1 viral load test. The HIV viral load test utilizes the FDA-approved high pure system viral nucleic acid kit for manual specimen preparation and the COBAS ...
Tags: HIV-1 viral load test, COBAS TaqMan, FDA