Hansen Medical is showcasing its Magellan Robotic system at the 2012 Vascular Annual Meeting of the Society for Vascular Surgery at Gaylord National Resort & Convention Center in National Harbor, Maryland, US. Hansen Medical president ...
Sunshine Heart has obtained a conditional approval from the US Food and Drug Administration (FDA) for its investigational device exemption (IDE)) implantable heart assist device. The non-blood contacting C-Pulse Heart Assist device, ...
Tags: C-Pulse IDE Device, FDA, clinical trial
The US Food and Drug Administration (FDA) has granted 510(k) clearance to NeuroMetrix's Sensus pain management system, designed as a treatment for painful diabetic neuropathy. The Sensus system is designed for use as a non-invasive ...
Exact Sciences has completed enrolling patients in its DeeP-C pivotal trial, designed to compare the accuracy of the stool DNA test in screening colorectal cancer with traditional screening methods. The test uses stool samples collected ...
Tags: Exact Sciences, DeeP-C pivotal trial, colorectal cancer
Sunshine Heart has submitted an investigational device exemption (IDE) application of its C-Pulse Heart Assist system to the US Food and Drug Administration (FDA) for approval. The basis of the IDE application is for the initiation of ...
Tags: FDA, medical system, medical technology
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Nanosphere's CYP2C19 nucleic acid test to determine gene variants affecting drug metabolism. The CYP2C19 enzyme, in general, metabolizes approximately 15% of all ...
Tags: FDA, CYP2C19 enzyme, automated sample-to-result Verigene system
Sunshine Heart is planning to initiate a US pivotal trial on its C-Pulse Heart Assist device in the fourth quarter of 2012, as it received an unconditional approval from the US Food Drug Administration (FDA). The CE marked system, ...
Tags: FDA, clinical trial, medical system
A new clinical study found that Bayer's blood glucose monitoring (BGM) system CONTOUR Next EZ meter and CONTOUR Next test strips proved easy to use and highly accurate when used by both patients and their healthcare professionals (HCPs). ...
Tags: medical system, clinical trial, blood glucose monitoring system
GenMark Diagnostics has obtained the US Food and Drug Administration's (FDA) 510(k) clearance for its eSensor Respiratory Virus Panel, designed for use on its XT-8 system. The test is intended to simultaneously detect and differentiate 14 ...
Tags: GenMark, FDA clearance, eSensor Respiratory Virus Panel, XT-8 system
The US Food and Drug Administration (FDA) has granted 510(k) clearance to AngioDynamics' BioFlo peripherally inserted central catheters (PICCs) with a permanent and non-eluting integral polymer Endexo technology. The BioFlo PICCs is ...
Tags: FDA, clearance, PICCs, BioFlo PICCs, PASV Valve technology
Philosys is looking forward for the US Food and Drug Administration (FDA) approval of its new Gmate blood glucose monitoring system in third quarter 2012. By utilizing Smartphone technology, Gmate blood glucose meter works with the ...
Tags: Philosys, FDA approval, blood glucose monitoring system
The AtriCure has obtained the US Food and Drug Administration (FDA) clearance to commence three-year Ablate post approval study (PAS), designed for the surgical correction of atrial fibrillation. The 350 patient study is designed to ...
Tags: AtriCure, FDA clearance, post approval study, PAS, Synergy ablation system
The US Food and Drug Administration (FDA) has granted 510(k) clearance to TomTec Imaging Systems' new image management solution. The Image-Com 5 software solution, which is the newest addition to TomTec's Image-Arena image management ...
The US Food and Drug Administration (FDA) has cleared Carestream's new lesion management module, designed to help enhance both diagnostic confidence and radiologist productivity. The new tool, which is designed for use with the ...
Bracco Diagnostics has obtained the US Food and Drug Administration (FDA) clearance for use of its MultiHance (gadobenate dimeglumine) injection, 529 mg/mL, in magnetic resonance angiography (MRA), designed to evaluate adults with known or ...
Tags: FDA, Bracco, clearance, MultiHance injection, MRA