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CE mark approvals
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FDA 510(K) Approval for Maternal/Fetal Monitoring System Is Obtained by Sense4baby
Dec 5, 2013US-based Sense4Baby has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its smartphone-based maternal/fetal monitoring system. The company has also obtained CE Mark approval from the European Commission for its ...
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Boston Scientific's Direxion Torqueable Microcatheter Obtains FDA and CE Mark Approvals
Nov 22, 2013Boston Scientific, a medical device company, has obtained the US Food and Drug Administration clearance and CE Mark approval for its Direxion torqueable microcatheter, designed to facilitate selective access and delivery of diagnostic, ...
Tags: Boston Scientific, Microcatheter
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Medtronic Has Received Both FDA and The CE Approvals for Peripheral Angioplasty Balloon
Jun 6, 2013Medtronic has received both the US Food and Drug Administration (FDA) approval and the CE (Conformité Européenne) Mark clearance for its Pacific Plus percutaneous transluminal angioplasty (PTA), the new peripheral balloon ...
Tags: Angioplasty Balloon, Medicine
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Boston Scientific Enters Into an Agreement to Buy Mapping and Navigation Systems
Dec 17, 2012Boston 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
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IRIDEX Obtained FDA's 510(K) Approval and CE Mark for Non-Invasive Laser Delivery System
Dec 10, 2012IRIDEX has obtained FDA's 510(k) approval and CE mark for its non-invasive laser delivery system, designed for treating serious retinal diseases. Using MicroPulse technology, the new TxCell Scanning laser delivery system saves time in a ...
Tags: IRIDEX, non-invasive, laser delivery system, CE mark approvals
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Maquet Cardiovascular Has Gained US and European Marketing Rights
Dec 5, 2012Maquet Cardiovascular has gained US and European marketing rights for its new SENSATION PLUS 7.5Fr. 40Cc intra-aortic balloon (IAB) catheter, following the US Food and Drug Administration (FDA) and CE mark approvals respectively. The ...
Tags: marketing rights, catheter, FDA
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Covidien Will Market Its Nellcor Bedside Respiratory Patient Monitoring System
Dec 5, 2012Covidien will market its Nellcor bedside respiratory patient monitoring system in the US and European Economic Area (EEA), following the Food and Drug Administration and CE mark approvals. The new system, which can connect to the ...
Tags: respiratory monitoring system, FDA, clinical technology