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