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Simergent Announces FDA Clearance of the Archimedes™ Home Dialysis System

October 14, 2025

OKLAHOMA CITY and CHICAGO, Oct. 14, 2025 /PRNewswire/ — Simergent, a privately held company dedicated to advancing treatment for patients with kidney failure, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s Archimedes™ automated peritoneal dialysis (APD) system for the treatment of patients with End Stage Kidney Disease (ESKD) in clinical and home settings.

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Centinel Spine® Receives Two-Level FDA Approval for prodisc® C Vivo and prodisc® C SK Match-the-Disc™ Cervical Total Disc Replacement Devices

October 14, 2025

WEST CHESTER, Pa., Oct. 14, 2025 /PRNewswire/ — Centinel Spine®, LLC (“the Company”), the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®), today announced U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for 2-level indications for the prodiscC Vivo and prodisc C SK Cervical TDR devices. Since receiving FDA approval for 1-level indications in July 2022, nearly 20,000 prodiscC Vivo and prodisc C SK spinal levels have been implanted in the U.S. by over 1,100 surgeons.

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Amplifi Vascular Announces Successful First-in-Human Study Results, Closes $6.8M Series A, and Receives FDA IDE Approval

October 9, 2025

ST. LOUIS, Oct. 9, 2025 /PRNewswire/ — Amplifi Vascular, developer of the first-of-its-kind Vein Dilation System designed to increase eligibility, improve creation and early maturation of arteriovenous fistulas (AVFs) for hemodialysis, today announced three major milestones: positive first-in-human (FIH) study results, the close of a $6.9 million Series A financing, and U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE).

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