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 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
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
CardioComm Solutions is seeking FDA clearance for its GUAVA II, a new ECG viewer with ECG algorithm technologies. GUAVA is a medical software device with a formal Application Programming Interface (API) and can be incorporated from Host ...
Tags: CardioComm, FDA, clearance, GUAVA II, ECG viewer
The US Food and Drug Administration (FDA) has cleared Aimago's new tablet-based diagnostic imaging tool to identify poorly perfused tissue. The non-invasive EasyLDI perfusion assessment device uses the laser doppler imaging (LDI) ...
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
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
The US Food and Drug Administration (FDA) has granted 510(k) clearance to NEC Display Solutions' 3-megapixel medical diagnostic display, designed for viewing digital mammography images for diagnosis. The new 21.3-inch display, MultiSync ...
Tags: FDA, NEC, medical diagnostic display, digital mammography images
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
Tangent Medical has gained FDA 510(k) clearance for the NovaCath Secure IV Catheter System designed to address peripheral IV challenges including catheter stabilization, healthcare worker safety, tubing management and patient comfort. ...
Tags: FDA, Catheter System, medical device, clinical technology
The US Food and Drug Administration (FDA) has cleared Covalon's SurgiClear antimicrobial silicone adhesive film dressing. SurgiClear antimicrobial silicone dressing is designed to cover and protect wound sites and wound closure ...
Tags: FDA, dhesive film dressing, clinical product, clinical application
GeNO has received four additional US patents for its proprietary nitric oxide (NO) generation chemistry and delivery technology. The patent No. 8,211,368 describes the conversion of nitrogen dioxide (NO2) to NO where NO2 is stored as ...
Tags: US patent, clinical technology, clinical research, GeNO
Merit Medical Systems has gained US marketing rights for its ONE Snare Endovascular Snare system, following the Food and Drug Administration's (FDA) approval. Single-loop snare system is designed to provide both accuracy and reliability ...
Tags: Merit Medical Systems, ONE Snare Endovascular Snare system, FDA
Volcano, a manufacturer of precision guided therapy tools, has entered into an agreement to buy US-based Crux Biomedical for $36m in cash. Crux Biomedical's product includes the Crux VCF system, an inferior vena cava (IVC) filter, which ...
Tags: precision guided therapy tools, buy.Crux Biomedical, Crux VCF system