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EndoArt(R)

EyeYon Medical Ltd. Receives FDA IDE Approval for U.S. Clinical Study of EndoArt®, the First Artificial Endothelial Layer for Corneal Edema

EyeYon Medical Ltd., a global leader in ophthalmic innovation, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to initiate a U.S. clinical study of EndoArt®, the world's first synthetic endothelial layer for the treatment of chronic corneal edema. EndoArt® is currently designated by the FDA as a Breakthrough Device.

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Kardium's Globe Pulsed Field System

Kardium begins first commercial procedures with the Globe® Pulsed Field System, a breakthrough in atrial fibrillation treatment

Kardium, a private medical device company that’s advancing the way the world treats atrial fibrillation (AF), announced the successful completion of the first commercial procedures using its integrated mapping and ablation system, the Globe Pulsed Field System, following recent approval from the U.S. Food and Drug Administration (FDA).

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RefleXion X1

First clinical outcomes for SCINTIX therapy in lung and bone tumors unveiled by RefleXion Medical

RefleXion Medical, an external‑beam theranostic oncology company, announced first results from the PREMIER Registry (NCT05406167) evaluating its SCINTIX® biology-guided radiotherapy, or BgRT, platform in patients with lung and bone tumors. The findings, presented at the 2025 ASTRO Annual Meeting, showed local control of 100 percent at nine months post-treatment with no reported Grade 2 or higher adverse events. The data represent the first prospective, multi-institutional evidence of SCINTIX therapy’s clinical impact.

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Symphony Thrombectomy System

Imperative Care announces FDA clearance of the Symphony Thrombectomy System, the first large-bore continuous vacuum system for treating pulmonary embolism

Imperative Care, Inc announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Symphony® Thrombectomy System to treat pulmonary embolism (PE), a life-threatening condition caused by blood clots blocking an artery in the lungs.

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