The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel's non-instrumented molecular diagnostic assay, designed for the detection of toxigenic Clostridium difficile (C difficile) bacterial DNA. The AmpliVue C. ...
Tags: FDA, Non-Instrumented C Difficile Detection Assay, medical technology
Elekta has gained 510(k) clearance for its Clarity 4D Monitoring software, allowing US medical centers to deploy a new way of minimizing the uncertainty caused by prostate motion during radiation treatment. Clarity 4D Monitoring ...
Tags: 4D Monitoring software, Elekta, US medical centers, medical technology
Teleflex has received FDA 510(k) clearance to market its pressure injectable ARROW PICC preloaded with the ARROW VPS Vascular Positioning System Stylet. The preloaded ARROW PICC enables clinicians to save the time and process of ...
Tags: FDA, Teleflex, medical system
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex Incorporated's new line of Weck reusable obturators, designed for use during laparoscopic procedures. The stainless steel obturators, which are ...
Tags: FDA, laparoscopic procedure, medical tool, medical technology
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 ...
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
Surefire Medical, a developer of infusion systems, has received CE mark approval for its new Surefire infusion system, designed for use in chemo and radioembolization procedures. The CE mark approval is based on a recent retrospective ...
Tags: CE mark, infusion system, Surefire
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
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 granted 510(k) clearance to Teleflex for its new disposable endobronchial blocker. The Rusch EZ-Blocker features a bifurcated distal end and dual bronchial cuffs, which allow physicians to ...
Tags: FDA, disposable endobronchial blocker, clinical product
Bausch + Lomb and Technolas Perfect Vision have received 510(k) clearance from the US Food and Drug Administration (FDA)for Victus Femtosecond Laser platform, designed for use during cataract and corneal surgical procedures. The CE-marked ...
Tags: FDA, Victus platform, surgical procedures, platform
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Flexible Stenting Solutions' additional sizes of FlexStent Biliary Self-Expanding Stent system including 9 and 10mm diameters in lengths up to 100mm. The FlexStent ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Covidien's Nellcor bedside SpO2 patient monitoring system. The Nellcor bedside SpO2 monitor, which utilizes OxiMax technology, is designed for detecting heart rate ...
Tags: FDA, clearance, Nellcor, SpO2 patient monitoring system, SpO2 monitor
Thermedical has obtained 510(k) clearance for its radiofrequency-based thermal ablation system, designed for treating large volumes of solid tumors, from the US Food and Drug Administration (FDA). Featuring a single or more needles, the ...
Tags: Thermedical, thermal ablation system, FDA, radiofrequency waves, approval