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- CERTIFICATIONS

Texas Cardiac Arrhythmia Institute at St. David’s Medical Center first in U.S. to use FDA-approved novel wireless system to treat cardiac arrhythmias

AUSTIN, Texas, July 21, 2025 /PRNewswire/ — Electrophysiologists at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center recently became the first in the nation to implant an FDA-approved novel leadless system that provides cardiac resynchronization therapy to patients with heart failure. Cardiac resynchronization therapy improves the timing of the heart’s contractions, helping to restore the normal rhythm of the heartbeat. The first procedure was recently performed by Robert Canby, M.D., cardiac electrophysiologist at TCAI.

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Saluda Medical Announces Full U.S. Launch of EVA™ Sensing Technology for Use with the Evoke® SmartLoop™ System

MINNEAPOLIS, July 17, 2025 /PRNewswire/ — Saluda Medical, Inc., a pioneer in the development and commercialization of a novel neuromodulation platform designed to transform the lives of patients with chronic neurological conditions, today announced the full commercial launch of EVA, its next-generation sensing technology, in the United States (U.S.). EVA received U.S. Food & Drug Administration (FDA) approval in December 2024 and is compatible with all commercially implanted Evoke® SmartLoop™ System patients.

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Piccolo Medical, Inc. Receives FDA Clearance for 2nd Generation SmartPICC® technology

SAN FRANCISCO, July 16, 2025 /PRNewswire/ — Piccolo Medical, Inc. (Piccolo), a leading innovator in vascular access technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its next-generation SmartPICC® Stylet and PM2+™ System. This significant achievement marks a major leap forward in safe, efficient, and cost-effective peripherally inserted central catheter (PICC) placement, offering enhanced benefits for both patients and healthcare providers.

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RIVANNA’s next-generation ultrasound guidance platform and AI-driven imaging software receive FDA 510(k) clearance

CHARLOTTESVILLE, Va., July 16, 2025 /PRNewswire/ — RIVANNA®, developers of world-first imaging-based medical technologies, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) regarding the Accuro® 3S diagnostic ultrasound system and SpineNav-AI™ image processing software. This clearance authorizes the use of both technologies in United States hospital and clinical settings, providing anatomical guidance during needle or catheter placement.

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