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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.

Kardium Inc. announced today the successful completion of enrollment in the paroxysmal cohort of the pivotal PULSAR IDE (Investigational Device Exemption) study.

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.

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.

Establishment Labs Holdings Inc. noted the presentation today of an update on the Motiva US IDE Study.

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.

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.

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.

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).

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.