Insulet, a provider of tubeless insulin pump technology, has reported a net loss of $12.42m, or $0.26 per share, for the third quarter ended 30 September 2012 compared to a net loss of $13.56m, or $0.29 per diluted share, for the third ...
Tags: Insulet, tubeless insulin pump technology, Financial situation
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 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 granted 510(k) clearance to SomnoMed's SomnoDent G2 technology. SomnoDent G2 includes modular adjustment parts and features 'Click to Fit' design which provides controlled measurement of a ...
Tags: SomnoDent G2 technology, diagnostic solution, medical solution
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Vitacon's VitaScan LT USB bladder scanner, designed for measuring bladder volume in real-time which avoids the placement of indwelling urethral catheters, a major ...
Tags: bladder scanner, FDA, clinical device
The US Food and Drug Administration (FDA) has granted 510(k) clearance to NovaBay Pharmaceuticals' NeutroPhase skin and wound cleanser for use in moistening and debriding graft and donor sites. The approval allows the company to use ...
Tags: FDA, wound cleanser, clinical application
Teleflex's Arrow FlexTip Plus Closed Tip, multi-port epidural catheter has been granted 510(k) clearance by the US Food and Drug Administration (FDA). The Arrow FlexTip Plus Closed Tip catheter utilizes the same technology of the ...
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 granted 510(k) clearance to Surefire Medical's new line of Angiographic catheters. Angiographic Catheter line features a large inner lumen of 0.054 inches which enables interventional ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Zynex's InWave device, designed for treating female urinary incontinence. Following the approval, the company said the InWave device will be manufactured, ...
Tags: FDA, female urinary incontinence, clinical application, clinical product
ETView Medical has obtained European pre-market clearance for Viva-EB line of endobronchial blockers. The Viva-EB product family are designed to provide endobronchial blockade of the right or left lung for thoracic surgical procedures ...
Tags: Viva-EB line of endobronchial blockers, clinical application, CE Mark
BG Medicine has obtained CE mark approval for its diagnostic blood assay, CardioSCORE, designed for identifying individuals who are at high risk for near-term major cardiovascular events including heart attack and stroke. The multivariate ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Biosign Technologies' non-invasive blood pressure measurement system, Pulsewave monitor. The UFIT EN-10 monitor is worn on the wrist having 13.5 cm to 23 cm (5.3 ...
Tags: FDA, blood pressure measurement system, pulsewave monitor, systolic
Precision Spine, the parent company of Spinal USA, has announced FDA 510(k) clearance of the Slimplicity solo anterior cervical plate system. The Spinal USA's Slimplicity new anterior cervical plate system, which consists of one and two ...
Tags: Spinal USA, FDA 510(k)clearance, solo anterior cervical plate system
Mevion Medical Systems, a radiation therapy company, has received FDA 510(k) clearance for its MEVION S250 Proton Therapy System. The MEVION S250, powered by a patented TriNiobium Core, provides the delivers precise and intense proton ...
Tags: Mevion Medical, FDA 510(k)clearance, MEVION S250, Proton Therapy System