Blog

- ANNOUNCEMENTS

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

NES ZIONA, Israel, Dec. 8, 2025 /PRNewswire/ — 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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VSI® Performs World’s First Robotic Minimally Invasive Bertolotti Resection Surgery

RESTON, Va., Nov. 25, 2025 /PRNewswire/ — VSI® Spine Surgeon Dr. Christopher Good has achieved a historic milestone in robotic spine surgery, performing the world’s first minimally invasive robotic Bertolotti’s resection surgery at Reston Hospital Center (HCA Virginia Health System). This first-ever procedure introduces a transformative surgical option for patients suffering from chronic low back pain caused by Bertolotti syndrome, an underdiagnosed spinal condition affecting an estimated 4-8% of the population.

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Regenity Biosciences Marks 63rd FDA 510(k) Clearance with Expansion of Neurosurgical Portfolio

PARAMUS, N.J., Nov. 25, 2025 /PRNewswire/ — Regenity Biosciences, a global leader in regenerative medicine and Linden Capital Partners portfolio company, today announced its 63rd FDA 510(k) clearance for DuraMatrix® Repair – Collagen Dura Regeneration Membrane, a resorbable membrane composed of highly purified Type I and Type III bovine collagen for the repair of dura mater defects during neurosurgery.

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