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510 K approval
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Google Has Lengthened Its Leap Into Medtech by Acquiring Lift Labs
Sep 16, 2014Google has lengthened its leap into medtech by acquiring Lift Labs, a San Francisco startup that makes a spoon to help prevent patients with movement disorders from spilling their food. The Internet giant will fold Lift Labs into Google ...
Tags: movement disorders, spoon
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Medtech Manufacturers May Soon Have Clearer Guidelines on How to Get Their Products
Aug 14, 2014Medtech manufacturers may soon have clearer guidelines on how to get their products through the FDA’s 510(k) process—with the changes meant to address the widespread criticism of the regulatory pathway in recent years by ...
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Biofortuna Receives 510(K) Approval From FDA for Its Line of Sspgo HLA PCR Kits
Feb 28, 2014UK-based Biofortuna has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its line of SSPGo HLA PCR kits, designed for transplantation genotyping and identification of genes that may be associated with various ...
Tags: Biofortuna, Medicine
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Benvenue Medical Obtains Approval From FDA for Its Kiva VCF Treatment System
Feb 7, 2014Benvenue Medical, a medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Kiva VCF treatment system for the reduction and treatment of spinal fractures. The FDA marketing clearance is ...
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FDA Approval for Probeam Proton Therapy System Was Obtained by Varian Medical Systems
Jan 17, 2014US-based medical device company Varian Medical Systems has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its updated ProBeam proton therapy system. Using the ProBeam system, clinicians can deliver the dose ...
Tags: Varian Medical, IMPT, ProBeam system
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FDA 510(K) Approval for Microcutter Xchange 30 Cutting/Stapling Device Is Got by Cardica
Jan 13, 2014Cardica, a medical device company, has received 510(k) approval from the US Food and Drug Administration (FDA) for its MicroCutter Xchange 30 device and blue staple cartridge for medium thickness tissue. The company has designed the ...
Tags: Cardica, medical device
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510(K) Approval From FDA Has Been Obtained by Philips
Dec 23, 2013The Netherlands-based Royal Philips has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the spectral breast density measurement application for use with its MicroDose SI full-field digital mammography (FFDM) ...
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FDA 510(K) Approval for Bone Anchored Sound Processors Is Obtained by Oticon Oticon Medica
Dec 20, 2013Oticon Medical, a manufacturer of bone anchored hearing systems, has obtained 510(k) approval the US Food and Drug Administration (FDA) to market its Ponto Plus bone anchored sound processors in regular version (down to a hearing loss of ...
Tags: Oticon Medical, Ponto Plus Bone
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FDA 510(K) Approval for Harmonic Focus+ Shears Has Been Obtained by Ethicon
Dec 13, 2013Ethicon Endo-Surgery has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its HARMONIC FOCUS+ shears with adaptive tissue technology. HARMONIC FOCUS+ now brings adaptive tissue technology to open procedures ...
Tags: Ethicon, HARMONIC FOCUS+, adaptive tissue, technology, HARMONIC
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FDA 510(K) Approval of Retroarc Retropubic Sling System Is Obtained by American Medical
Dec 11, 2013American Medical Systems, a provider of devices and therapies for male and female pelvic health, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its RetroArc retropubic sling system. Designed for the ...
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FDA 510(K) Approval for Microcyn Scar Management Hydrogel Is Obtained by Oculus
Dec 9, 2013Oculus Innovative Sciences has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Microcyn scar management HydroGel, intended to manage old and new hypertrophic and keloid scarring resulting from burns, ...
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FDA 510(K) Approval for Breast Cancer Image Analysis Algorithm Is Obtained by Ventana
Dec 9, 2013Ventana Medical Systems, a member of the Roche Group, has obtained the US Food and Drug Administration’s (FDA) 510(k) approval for its Companion Algorithm ER (SP1) image analysis algorithm used with the Ventana iScan Coreo scanner ...
Tags: Breast Cancer, Analysis Algorithm
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Regulatory Approval to Market Its Flex+2 Products in Brazil Is Received by Spinevision
Dec 9, 2013SpineVision, a medical device company, announced that it has expanded its Flex+2 dynamic stabilization platform offerings with the addition of the prebent Flex+2 for use in hybrid cases and has received regulatory approval to market its ...
Tags: SpineVision, Flex+2 Products
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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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FDA 510(K) Approval for ICEPlex System Has Been Obtained by PrimeraDx
Dec 5, 2013PrimeraDx, a molecular diagnostics company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its ICEPlex C. difficile assay kit and the ICEPlex system. The ICEPlex system is a multiplex real-time PCR system ...