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
Sorin Group has announced the US launch of a Mitroflow Valsalva Conduit graft, designed for use in combination with a Mitroflow pericardial aortic valve. The Conduit graft enables surgeons to replace simultaneously the ascending aorta and ...
Tags: Sorin, launch, Conduit graft, combination, Mitroflow graft
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
American medical device firm Kips Bay Medical's eMESH I clinical feasibility trial has moved a step further, with first patient enrolling to the study at a European hospital. Switzerland-based Bern University Hospital has recently ...
Tags: eSVS Mesh, Kips Bay, CABG Surgery
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
Biotronik has reported that the first US patient has been implanted with its Lumax 740 dual-chamber implantable cardioverter defibrillator (ICD). Lumax 740 dual-chamber ICD features SMART detection, which discriminate between atrial and ...
Tags: Lumax 740 dual-chamber implantable cardioverter defibrillator
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
Edwards Lifesciences is set to begin clinical trial to assess its Intuity valve system, following an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA). The prospective, multi-center study, ...
Tags: clinical trial, Intuity valve system, FDA
The US Food and Drug Administration (FDA) has granted approval to Pulmonx to commence an investigational device exemption (IDE) pivotal clinical study of its Zephyr Endobronchial Valve (EBV) therapy, designed to treat emphysema. The ...
Tags: FDA, Endobronchial Valve therapy, emphysema, Zephyr EBV therapy