Spacelabs Healthcare, a division of OSI Systems, has received the US Food and Drug Administration's 510(k) approval for its Blease900 ventilator. The Blease900 ventilator, which is an integral component of its BleaseFocus anesthesia ...
Tags: FDA, OSI Systems, Blease900 ventilator
Cook Medical has received the regulatory approval from the US Food and Drug Administration (FDA) for its Zilver PTX drug-eluting peripheral stent, designed for treating peripheral arterial disease (PAD) in the superficial femoral artery. ...
Tags: Cook Medical, FDA, peripheral arterial disease, 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
Endosense, a provider of cardiac technologies, has completed enrolling patients in its Toccastar clinical study. The prospective, randomized, multi-center investigational device exemption trial, which enrolled 300 patients with ...
Tags: Endosense, Toccastar clinical study, cardiac technologies
Spacelabs Healthcare, a subsidiary of OSI Systems, has obtained 510(k) approval for its new compact, sidestream gas analyzer, Capnography Pod, from the US Food and Drug Administration (FDA). Capnography Pod, which is compatible with the ...
Tags: Spacelabs, OSI Systems, approval, FDA
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
Cytomedix has featured its AutoloGel system at the Native American Wound Care Conference and Diabetic Limb Salvage Conference. The FDA-cleared AutoloGel system is designed for the production of autologous platelet rich plasma (PRP) for ...
Tags: Cytomedix, AutoloGel system, PRP, wound management
Ceretec has launched a nitric-oxide (NO) lung diffusion gas mixture, NO-Diff, for use in membrane diffusing capacity (DLNO) testing in pulmonary function laboratories in the US. The gas product, classified as Class 1 medical device by ...
Tags: medical device, lung diffusion gas mixture, clinical technology
Boston Scientific has received the US Food and Drug Administration (FDA) approval for 32 mm and 38 mm lengths of the Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent system. The Promus Element Stent is made with a ...
Tags: FDA, Boston Scientific, Promus Element Stent, coronary artery disease
Avinger has completed enrolling peripheral artery disease (PAD) patients in its CONNECT II clinical trial. The prospective, multi-center, non-randomized trial that evaluated 100 PAD patients with femoropopliteal CTO lesions was ...
Tags: clinical trial, peripheral artery disease, clinical technology, Avinger
Cordis has obtained regulatory approval from the US Food and Drug Administration (FDA) to use its S.M.A.R.T. CONTROL Vascular Stent systems in the superficial femoral artery (SFA) and/or the proximal popliteal artery (PPA). The Stent ...
Tags: FDA, Stent systems, proximal popliteal artery, superficial femoral artery
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Corindus Vascular Robotics' CorPath 200 system, designed to restore blood flow to blocked arteries in patients with coronary artery disease. The CorPath 200 system, ...
Tags: CorPath 200 system, robotically-assisted PCI, coronary artery disease
The US Food and Drug Administration (FDA) has cleared Echometrix's musculoskeletal visualization technology. The proprietary technology software, which is designed for compatibility with ultrasound equipment, generates color maps to help ...
Tags: FDA, Echometrix, musculoskeletal visualization technology, software