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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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Scopio Labs Receives Fourth FDA Clearance, Elevating Digital Morphology with Enhanced AI-Powered RBC and Platelet Capabilities

TEL AVIV, Israel, July 10, 2025 /PRNewswire/ — Scopio Labs, a trailblazer in Full-Field Digital Cell Morphology, today announced another significant milestone: its fourth U.S. Food and Drug Administration (FDA) clearance (K243144). This latest clearance introduces powerful new Decision Support System (DSS) features to its X100 and X100HT platforms and Peripheral Blood Smear (PBS) Application, further transforming the way laboratories analyze red blood cell (RBC) morphology and identify platelet clumps in peripheral blood smears.

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