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277,845 Results for "prisym id".
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Genetown
AVS Receives IDE Approval from FDA for Pivotal Intravascular Lithotripsy Study
Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease, announced today that it has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin its pivotal trial for pulsatile intravascular lithotripsy (PIVL) therapy.
June 6, 2024
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2 min read
Kardium Announces Completion of Paroxysmal Enrollment in the PULSAR IDE Study
Kardium Inc. announced today the successful completion of enrollment in the paroxysmal cohort of the pivotal PULSAR IDE (Investigational Device Exemption) study.
April 2, 2024
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3 min read
Venus Medtech VenusP-Valve Completed First Implantation in IDE Pivotal Clinical Study in U.S.
Venus Medtech, a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced that its in-house developed innovative transcatheter pulmonic valve replacement system, VenusP-Valve, has completed its first implantation in the PROTEUS IDE Pivotal Clinical Study at the University of Virginia School of Medicine.
June 14, 2024
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4 min read
Policy
DeepQure receives IDE Approval from FDA for its EFS study to treat Resistant Hypertension with its Extravascular Renal Denervation Technology (HyperQure™)
DeepQure, a Seoul based medical device company with a novel, extravascular solution for renal denervation, announced initiation of its Early Feasibility Study for the HyperQure™ system following FDA IDE approval.
June 10, 2024
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2 min read
Pharm Country
Establishment Labs Notes Presentation of 4-Year Results from Motiva U.S. IDE Study at The Aesthetic Meeting 2024
Establishment Labs Holdings Inc. noted the presentation today of an update on the Motiva US IDE Study.
May 2, 2024
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7 min read
Drug Development
IDEAYA Biosciences Announces First-Patient-In for Phase 1 Clinical Trial Evaluating IDE397 and Trodelvy® Combination in MTAP-Deletion Bladder Cancer
IDEAYA Biosciences, Inc. announced that it has dosed its first patient in the IDEAYA-sponsored Phase 1 trial evaluating the combination of IDE397, IDEAYA’s investigational MAT2A inhibitor, and Trodelvy®, Gilead’s Trop-2 directed ADC, in patients with MTAP-deletion bladder cancer.
June 25, 2024
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5 min read
Drug Development
IDEAYA Biosciences Announces Clinical Program Updates for IDE397 a Potential First-in-Class Phase 2 MAT2A Inhibitor Targeting MTAP-Deletion Solid Tumors
IDEAYA Biosciences, Inc., a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced clinical program updates for IDE397, a potential first-in-class Phase 2 MAT2A inhibitor targeting MTAP-deletion solid tumors.
June 24, 2024
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5 min read
Raydiant Oximetry Secures FDA Approval for Lumerah Investigational Device Exemption (IDE) Study
Raydiant Oximetry, Inc. announces that the United States Food and Drug Administration (FDA) has approved the Investigational Device Exemption (IDE) of the Lumerah™ technology for an Early Feasibility Study (EFS) of pregnant women during labor and delivery.
April 10, 2024
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3 min read
LIPOGEMS ANNOUNCES LAST PATIENT ENROLLED IN THE U.S. FDA IDE ARISE STUDY FOR THE TREATMENT OF KNEE OSTEOARTHRITIS
Lipogems announces it has completed enrollment in the ARISE I U.S. FDA IDE study, which aims to examine MicroFat versus corticosteriod injection for the treatment of Knee Osteoarthritis (OA).
April 10, 2024
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2 min read
Biotech Bay
ZKR Orthopedics Receives IDE Approval for Clinical Trial
ZKR Orthopedics, Inc. announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial.
February 14, 2024
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3 min read
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