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Home » Clearances roundup: Calypso, CryoLife and SpineSmith

Clearances roundup: Calypso, CryoLife and SpineSmith

October 9, 2010 By MassDevice staff

Clearances roundup

Here’s a roundup of companies announcing regulatory clearances from the Food & Drug Administration and foreign regulatory agencies:

  • Calypso logo

    Calypso Medical receives FDA 510(k) for Dynamic Edge Gating Technology
    Calypso Medical Technologies, Inc., a developer of real-time localization technology used for the precise tracking of tumors, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Calypso System with Dynamic Edge Gating Technology.
    Read more

  • CRY logo

    CryoLife receives Japanese regulatory approval for BioGlue surgical adhesive
    CryoLife Inc. (NYSE:CRY), an implantable biological medical device and cardiovascular tissue processing company, announced that its BioGlue Surgical Adhesive has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for use in the repair of aortic dissections.
    Read more

  • SpineSmith logo

    SpineSmith Partners announces FDA clearance and product launch of VisuALIF interbody fusion device at North American Spine Society annual meeting
    SpineSmith Partners, a Texas-based medical device company, announced the company has received FDA clearance for commercial sale in the United States of its VisuALIF Interbody Fusion Implant System.
    Read more

  • DiFusion logo

    DiFUSION Technologies receives 510(k) clearance of Xiphos interbody implants for spinal fusion
    DiFUSION Technologies Inc., a medical device company focused on the development and commercialization of its proprietary CleanFUZE anti-microbial technology for orthopedic implants, announced the 510(k) clearance of its new Xiphos line of posterior interbody devices indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment.
    Read more

  • Centinel logo

    Centinel Spine receives 510(k) clearance for STALIF MIDLINE
    Centinel Spine Inc., a leader in developing Integrated Interbody Fusion devices, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its new STALIF MIDLINE system.
    Read more

  • NIMU logo

    NIMS signs Mexican distributor and obtains Mexican approval for Exer-Rest
    Non-Invasive Monitoring Systems Inc. (OTC:NIMU) announced that the Mexican Ministry of Health has approved the registration of NIMS’ Exer-Rest acceleration therapeutic platform as a Class I medical device, and that NIMS appointed Medica Avante as its exclusive Mexican Exer-Rest distributor.
    Read more

  • IART logo

    Integra LifeSciences receives FDA clearance for multiple fixation options for Vu aPOD Prime ALIF device
    Integra LifeSciences (NSDQ:IART) announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Vu aPOD Prime anterior lumbar interbody fusion (ALIF) device.
    Read more

  • GPRO logo

    Gen-Probe files U.S. regulatory application for molecular test to detect common sexually transmitted disease trichomonas vaginalis
    Gen-Probe Inc. (NSDQ:GPRO) announced that the company has submitted a 510(k) application to the U.S. Food & Drug Administration (FDA) for its APTIMA Trichomonas vaginalis assay on the fully automated TIGRIS system.
    Read more

  • VITA logo

    Orthovita receives FDA clearance for VITOMATRIX bone graft substitute in dental applications
    Orthovita Inc. (NSDQ:VITA), an orthobiologics and biosurgery company, announced that it received 510(k) clearance from the U.S. Food & Drug Administration to market VITOMATRIX Bone Graft Substitute as a bone grafting material in certain dental procedures.
    Read more

  • EarlySense logo

    EarlySense’s EverOn Central Display Station (CDS) receives FDA clearance
    EarlySense announced that its EverOn Central Display Station (CDS) has been cleared for marketing by the U.S. Food and Drug Administration (FDA). The FDA clearance covers the ability of the system to collect real time vital sign information from up to 36 EverOn bedside monitors and display the information on a computer screen at the nurse’s station.
    Read more

  • DFine logo

    DFine announces FDA 510(k) clearance of new radiofrequency ablation system for metastatic spinal lesions
    DFine Inc., developer of minimally invasive solutions for the treatment of vertebral pathologies, announced the 510(k) clearance of a new platform extension indicated for the palliative treatment of cancer patients. The product, a percutaneous radiofrequency ablation (RFA) device, provides localized tumor necrosis of vertebral body lesions where metastatic disease has spread to the spine causing severe pain and discomfort.
    Read more

  • NovaBone logo

    NovaBone Putty MIS Delivery System approved by FDA for orthopedic surgery
    NovaBone Products, a medical device company, announces the U.S. Food and Drug Administration’s (FDA) approval of the NovaBone Putty MIS Delivery System designed for use in minimally invasive orthopedic procedures.
    Read more

  • Zone Life logo

    Zone Life obtains FDA clearance and launches i-Lipo Ultra: The latest body contouring treatment
    Zone Life, a New York City-based lifestyle company featuring the newest innovations in the beauty, fitness and nutrition industries, announced that it has received FDA clearance to market i-Lipo Ultra, the latest body-contouring device in the United States.
    Read more

  • Wenzel Spine logo

    Wenzel Spine gains 510(k) clearance to market the VariLift stand-alone expandable interbody fusion system
    Wenzel Spine Inc., a medical device company focused on offering less invasive, stand-alone alternatives to traditional spinal fusion, today announced they have received 510(k) clearance to market the VariLift Expandable Interbody Fusion System.
    Read more

  • QDEL logo

    Quidel announces FDA clearance of its QuickVue RSV 10 immunoassay diagnostic test
    Quidel Corp. (NSDQ:QDEL), a leading provider of rapid diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its QuickVue RSV 10, a lateral flow immunoassay test for the qualitative detection of acute respiratory syncytial virus (RSV) infections.
    Read more

  • GTHP logo

    Guided Therapeutics files premarket approval application for non-invasive cervical cancer scanner with FDA
    Guided Therapeutics Inc. (OTC:GTHP) announced that it filed its completed premarket approval application (PMA) for the LightTouch Cervical Scanner with the U.S. Food and Drug Administration (FDA) for patients at risk for cervical cancer.
    Read more

  • QMDT logo

    Quick-Med’s NIMBUS technology receives approval from India FDA
    Quick-Med Technologies Inc. (OTC:QMDT), a life sciences company that is developing innovative technologies for the healthcare and consumer markets, announced today that its proprietary NIMBUS antimicrobial technology has been approved for manufacture, marketing and sale in India.
    Read more

  • ARTC logo

    ArthroCare receives FDA clearance for Parallax Contour vertebral augmentation device
    ArthroCare Corp. (NSDQ: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Parallax Contour Vertebral Augmentation Device (Contour) specifically for void creation in a vertebral body followed by injection of bone cement.
    Read more

  • Cook logo

    Cook Medical files pre-market approval application for FDA approval of a balloon expandable stent for renal artery disease
    Cook Medical has submitted its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its new balloon expandable stent for renal artery disease.
    Read more

  • AngelMed logo

    Angel Medical Systems receives CE Mark approval for the AngelMed Guardian, an implantable device designed to provide early warning of a heart attack
    Angel Medical Systems announced today that it has received CE (Conformite Europeenne) Mark approval for the commercial sale of the AngelMed Guardian System in Europe. The Guardian System is an implantable early warning system designed to detect coronary occlusion from thrombotic events such as plaque ruptures and alert the patient, often before symptom onset.
    Read more

  • Bioconnect logo

    Bioconnect Systems gains CE Mark approval for Optiflow anastomotic system
    Bioconnect Systems, Inc. today announced CE mark approval for the Optiflow Vascular Anastomotic System. The Optiflow enhances a surgeon’s ability to create precise vascular connections. The initial indication is the creation of an arteriovenous fistula needed for vascular access in hemodialysis patients.
    Read more

Filed Under: Business/Financial News, News Well Tagged With: Gift Bans

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