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pivotal clinical trial
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Total Artificial Heart Might Be The Next Potential Medtech Goldmine
Sep 10, 2014It's too early to tell, but the total artificial heart might be the next potential medtech goldmine. Shares of artificial heart maker Carmat climbed nearly 20% in mid-day trading on September 5 amidst recently-confirmed rumors that the ...
Tags: Health, Medicine, Artificial hearts
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Integra Lifesciences Has Announced The Completion of Patient Enrollment
Dec 25, 2013Integra LifeSciences, has announced the completion of patient enrollment in a pivotal clinical trial designed to assess the safety and effectiveness of Integra dermal regeneration template in the treatment of diabetic foot ulcers. Integra ...
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First Human Implant of Micra Transcatheter Pacing System Was Reported by Medtronic
Dec 11, 2013US-based Medtronic has announced that its Micra transcatheter pacing system (TPS) has been implanted in the first patient in Austria as part of the company’s multi-center global clinical trial. The single-arm, pivotal clinical trial ...
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Positive Results From Desolve Nx Clinical Trial Were Reported by Elixir Medical
Nov 4, 2013US-based Elixir Medical has announced positive one-year results from the DESolve Nx international pivotal clinical trial for the CE Mark-approved, fully bioresorbable DESolve Novolimus eluting coronary scaffold system. At one year, the ...
Tags: Elixir Medical, NX Clinical Trial
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St.Jude Medical Has Completed The Acquisition of Nanostim
Oct 15, 2013St. Jude Medical, a global medical device company, has completed the acquisition of Nanostim, a developer of miniaturized, leadless pacemakers. St. Jude Medical and Nanostim have entered into a series of agreements in May 2011, pursuant ...
Tags: St.Jude Medical, medical device
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Neuros Medical Has Obtained an IDE Clearance From FDA to Initiate a Randomized
Oct 12, 2013Neuros Medical, a US-based neurostimulation company, has obtained an investigational device exemption (IDE) clearance from the US Food and Drug Administration (FDA) to initiate a randomized, controlled pivotal clinical trial to evaluate the ...
Tags: Neuros Medical, Altius System
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DSMD has recommended the continuation of pivotal clinical trial of the APPY1 test
Sep 27, 2013US-based in vitro diagnostic company Venaxis announced that the Data and Safety Monitoring Board (DSMD) has recommended the continuation of pivotal clinical trial of the APPY1 test, a multiple biomarker-based assay for identifying patients ...
Tags: Appy1 Test, Clinical Trial
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T2 Biosystems Has Initiated The DirecT2 Clinical Trial of T2Candida
Sep 10, 2013T2 Biosystems has initiated the direcT2 clinical trial of T2Candida, designed for the rapid and sensitive identification of five species of Candida. The direcT2 trial will provide data to support a regulatory submission for T2Candida. ...
Tags: T2 Biosystems, Clinical Trial
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Edwards Lifesciences Obtained The Reimbursement for Sapien Xt Transcatheter Aortic Implant
Aug 26, 2013Edwards Lifesciences has obtained the reimbursement for its Sapien XT transcatheter aortic valve implant from Japan's Central Social Insurance Medical Council (Chuikyo) after the recommendation made by the Japanese Ministry of Health, Labor ...
Tags: XT Valve, Edwards Lifesciences
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US FDA Panel Decide on Ocular Premarket Approval Application for The Resure Sealant
Aug 12, 2013The US Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel is scheduled to decide on Ocular Therapeutix’s premarket approval application for the ReSure Sealant in September and may suggest some recommendations. ...
Tags: Ophthalmic Devices, Health
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Patient Enrollment in Weight Loss Device Pivotal Study Is Completed by ReShape
Feb 28, 2013ReShape Medical has completed patient enrollment in a pivotal clinical trial of its ReShape Duo Intragastric Balloon device, designed for the treatment of obese. Using a standard endoscope, non-surgical weight loss device is placed in the ...
Tags: ReShape, weight loss device, Medical
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Full Patient Enrollment for Heartlight Trial Will Be Completed by Cardiofocus in 2013
Jan 17, 2013CardioFocus will complete full patient enrollment in a US pivotal clinical trial of its HeartLight catheter ablation system in 2013. The 350 patient-based trial, which is evaluating and comparing the safety and efficacy of the company's ...
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Fda Approval Belongs to Dune Medical for Breast Cancer Detection Device
Jan 4, 2013Dune Medical Devices' MarginProbe system, designed for the detection of breast cancer, has obtained premarket approval (PMA) from the US Food and Drug Administration (FDA). The system is an intra-operative tissue assessment tool which ...
Tags: Dune Medical, FDA Approval, Breast Cancer Detection Device, Medicine
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GI Dynamics Has Obtained Conditional Approval From The US FDA
Dec 7, 2012GI Dynamics has obtained conditional approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of its non-surgical EndoBarrier device. Flexible, tube-shaped EndoBarrier liner, which forms a physical ...
Tags: GI Dynamics, conditional approval, FDA, pivotal clinical trial
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AspenBio Pharma Submits Its AppyScore Blood-Based Test's Pre-IDE to FDA
Aug 8, 2012AspenBio Pharma has submitted its AppyScore blood-based test's pre-investigational device exemption (pre-IDE) to the US Food and Drug Administration (FDA). AppyScore blood-based test is designed to aid physicians in identifying children ...
Tags: pre-investigational device, pre-IDE device, AppyScore blood-based test