Search Results

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

Press Releases

Cyrus Biotechnology Announces Potent in vivo Redosability of an Engineered IdeS Protease for IgG-driven Autoimmune Disease, Demonstrating No Anti-drug Antibodies

December 11, 2024

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4 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

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

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