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
Boston Scientific has entered into a definitive agreement to buy a developer of-gener nextation mapping and navigation systems, Rhythmia Medical. US based Rhythmia Medical's mapping and navigation technologies are used with catheter ...
Tags: mapping and navigation system, acquisition, clinical technology
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
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
Anaxsys has filed its respiR8 continuous respiratory rate counter's 510(k) premarket notification application with the US Food and Drug Administration (FDA) for regulatory clearance. Electrochemical respiR8 device comprises a patented ...
Tags: Anaxsys, Electrochemical respiR8 device, FDA
iSonea has filed an over-the-counter version of a new asthma monitoring device's 510(k) application with the US Food and Drug Administration (FDA) for approval. SonoSentry, which is a rebranded non-prescription version of personal ...
Tags: iSonea, SonoSentry, FDA
Stryker Neurovascular has obtained the US Food and Drug Administration's (FDA) approval for its new clot removal technology, Trevo Pro Retriever. By utilizing proprietary Stentriever technology, the Trevo Pro Retriever removes blood clots ...
Tags: Stryker Neurovascular, FDA, approval, clot removal technology
Spacelabs Healthcare, a division of OSI Systems, has received 510(k) approval from the US Food and Drug Administration (FDA) for its AriaTele telemetry transmitter. AriaTele transmitter features an onboard display screen that presents ...
Tags: Spacelabs Healthcare, OSI Systems, AriaTele telemetry transmitter
The US Food and Drug Administration (FDA) has cleared VuCOMP's premarket approval (PMA) application for new version of M-Vu computer-aided detection (CAD) system. The new CAD system, M-Vu version 2, is designed for use in digital ...
Tags: FDA, CAD system, clinical technology
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
BioControl Medical is set to commence the second phase of its INcrease Of VAgal TonE in Heart Failure (INOVATE-HF) study, following the US Food and Drug Administration (FDA) approval. The CardioFit system, which comprises a stimulator, a ...
Tags: BioControl Medical, INcrease Of VAgal TonE in Heart Failure study
The US Food and Drug Administration (FDA) has granted 510(k) approval to Reflectance Medical's CareGuide Oximeter. CareGuide Oximeter monitors hemoglobin oxygen saturation of microvascular blood in skeletal muscle tissue (muscle ...
Tags: FDA, CareGuide Oximeter, clinical technology
The US Food and Drug Administration (FDA) has granted clearance to Roche's automated Elecsys HSV-1 IgG and HSV-2 IgG assays, designed for the determination of IgG class antibodies to HSV-1 and HSV-2 in human serum or plasma of sexually ...
Tags: FDA, clinical trial, medical device