Medis Medical Imaging Systems B.V. has received clearance from the U.S. Food and Drug Administration for its QAangio XA 3D technology (QFR). The technology offers a non-invasive imaging technique for the assessment of the functional significance of coronary lesions without the need for a pressure wire, nor adenosine.

Researchers at University of California San Diego School of Medicine found higher blood pressure and pesticide exposures in children associated with a heightened pesticide spraying period around the Mother’s Day flower harvest. The study, published online in the journal Environmental Research,1 involved boys and girls living near flower crops in Ecuador.

Terumo Medical Corp. is recalling the SoloPath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to a potential for the tip to dislodge from the outer rim of the sheath. This may result in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

Marvin Eng, M.D., structural fellowship director at Henry Ford Health System, and William O'Neill, M.D., director of the Henry Ford Hospital structural heart program, explain the mitral valve repair program at Henry Ford. The hospital performs a large number of transcatheter mitral valve repairs, including MitraClip, and is involved in trials for investigational device technologies.

A discussion with William O’Neill, M.D., director of the Henry Ford structural heart program, Ruth Fisher, MBA, vice president of the program, and Janet Wyman, NP, program manager. Henry Ford Hospital has built a large, high-volume structural heart program that includes use of cutting edge new technologies and devices.

Iodine-based CT contrast with ready for scanning with a Canon Aquilion One 320-slice CT system at Northwestern Medicine Central DuPage Hospital in the Chicago suburbs. It is not clear that contrast caused contract induced nephrapathy (CIN), also referred to as acute kidney injury (AKI) or contrast-associated acute kidney injury (CAAKI). Photo by Dave Fornell

Iodine-based contrast agents used in computed tomography (CT) and catheter-based angiography have been implicated as a cause of contrast-induced nephropathy (CIN). This has raised concern in recent years, especially in renally compromised patients, and imagers are looking for ways to reduce the contrast media dose levels they use.

Amarin Corp. plc announced that its supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) capsules has been accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this sNDA is Sept. 28, 2019. Because of the Priority Review designation, the timing of this PDUFA date is four months earlier than the anticipated standard ten-month review for applications.

Philips announced the three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE European randomized clinical trial (EU RCT). These two trials are part of a series of five trials evaluating the safety and efficacy of Stellarex .035″ low-dose1 drug-coated balloon (DCB) to restore and maintain blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral arterial disease. The results were evaluated compared to treatment with uncoated balloons, the current standard of care.

As part of the Consolidated Appropriations Act of 2018, pass-through payment status for LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use has been extended for an additional two years. This extension became effective Oct. 1, 2018 and will remain in effect through Sept. 30, 2020.

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