http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Thu, 21 May 2026 08:02:19 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/Corporate+News/Adagio+Medical+submits+FDA+application+for+heart+arrhythmia+device/26531752.html <p>Adagio Medical Holdings Inc. (NASDAQ: ADGM) submitted a premarket approval application to the U.S. Food and Drug Administration for its vCLAS Ventricular Ablation System to treat drug-refractory, recurrent, sustained monomorphic ventricular tachycardia in patients with structural heart disease.</p><p>The submission is supported by the FULCRUM-VT pivotal trial, which enrolled 209 patients across 20 electrophysiology centers. The trial achieved 97.4% acute clinical success and demonstrated 84.3% freedom from implantable cardioverter defibrillator shock at six months, with 2.4% major adverse events and a 78% reduction or elimination of anti-arrhythmic drug use.</p><p>The system uses Adagio's Ultra-Low Temperature Ablation technology to create lesions through cardiac http://www.streetinsider.com/Corporate+News/Adagio+Medical+submits+FDA+application+for+heart+arrhythmia+device/26531752.html Thu, 21 May 2026 08:02:19 -0400 ADGM http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Press+Releases/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html <p class="bwalignc"> <b><i>PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted</i></b> </p><p class="bwalignc"> <b><i>Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market</i></b> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) http://www.streetinsider.com/Business+Wire/Adagio+Medical+Submits+Premarket+Approval+Application+to+FDA+for+vCLAS%C2%AE+Ventricular+Ablation+System+for+the+Treatment+of+Ventricular+Tachycardia/26531699.html Thu, 21 May 2026 08:00:00 -0400 A.06822034 A.10745066 A.32635824 ADGM O.02054126 O.20026344 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html <p class="bwalignc"> <i>Advancing Toward Submission for PMA Approval Following Late-Breaking FULCRUM-VT Data</i> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the first quarter ended March 31, 2026. </p><p> <b>Recent Business Highlights:</b> </p><ul class="bwlistdisc"> <li> <strong>Pivotal results from the FULCRUM-VT trial presented in late-breaking session at Heart Rhythm Society 2026</strong> – the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic cardiomyopathies—which demonstrated 84% freedom from implantable cardioverter defibrillator (“ICD”) shock at six months, a promising safety http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html Tue, 12 May 2026 08:05:00 -0400 A.10745066 A.32635824 ADGM O.02054126 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html <p class="bwalignc"> <i>Advancing Toward Submission for PMA Approval Following Late-Breaking FULCRUM-VT Data</i> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the first quarter ended March 31, 2026. </p><p> <b>Recent Business Highlights:</b> </p><ul class="bwlistdisc"> <li> <strong>Pivotal results from the FULCRUM-VT trial presented in late-breaking session at Heart Rhythm Society 2026</strong> – the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic cardiomyopathies—which demonstrated 84% freedom from implantable cardioverter defibrillator (“ICD”) shock at six months, a promising safety http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html Tue, 12 May 2026 08:05:00 -0400 A.10745066 A.32635824 ADGM O.02054126 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html <p class="bwalignc"> <i>Advancing Toward Submission for PMA Approval Following Late-Breaking FULCRUM-VT Data</i> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the first quarter ended March 31, 2026. </p><p> <b>Recent Business Highlights:</b> </p><ul class="bwlistdisc"> <li> <strong>Pivotal results from the FULCRUM-VT trial presented in late-breaking session at Heart Rhythm Society 2026</strong> – the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic cardiomyopathies—which demonstrated 84% freedom from implantable cardioverter defibrillator (“ICD”) shock at six months, a promising safety http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html Tue, 12 May 2026 08:05:00 -0400 A.10745066 A.32635824 ADGM O.02054126 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html <p class="bwalignc"> <i>Advancing Toward Submission for PMA Approval Following Late-Breaking FULCRUM-VT Data</i> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the first quarter ended March 31, 2026. </p><p> <b>Recent Business Highlights:</b> </p><ul class="bwlistdisc"> <li> <strong>Pivotal results from the FULCRUM-VT trial presented in late-breaking session at Heart Rhythm Society 2026</strong> – the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic cardiomyopathies—which demonstrated 84% freedom from implantable cardioverter defibrillator (“ICD”) shock at six months, a promising safety http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html Tue, 12 May 2026 08:05:00 -0400 A.10745066 A.32635824 ADGM O.02054126 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html <p class="bwalignc"> <i>Advancing Toward Submission for PMA Approval Following Late-Breaking FULCRUM-VT Data</i> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the first quarter ended March 31, 2026. </p><p> <b>Recent Business Highlights:</b> </p><ul class="bwlistdisc"> <li> <strong>Pivotal results from the FULCRUM-VT trial presented in late-breaking session at Heart Rhythm Society 2026</strong> – the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic cardiomyopathies—which demonstrated 84% freedom from implantable cardioverter defibrillator (“ICD”) shock at six months, a promising safety http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html Tue, 12 May 2026 08:05:00 -0400 A.10745066 A.32635824 ADGM O.02054126 O.21503249 O.26228129 O.49933047 http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html <p class="bwalignc"> <i>Advancing Toward Submission for PMA Approval Following Late-Breaking FULCRUM-VT Data</i> </p> <p> LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the first quarter ended March 31, 2026. </p><p> <b>Recent Business Highlights:</b> </p><ul class="bwlistdisc"> <li> <strong>Pivotal results from the FULCRUM-VT trial presented in late-breaking session at Heart Rhythm Society 2026</strong> – the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic cardiomyopathies—which demonstrated 84% freedom from implantable cardioverter defibrillator (“ICD”) shock at six months, a promising safety http://www.streetinsider.com/Press+Releases/Adagio+Medical+Reports+First+Quarter+2026+Results+and+Meaningful+Clinical+Progress/26473458.html Tue, 12 May 2026 08:05:00 -0400 A.10745066 A.32635824 ADGM O.02054126 O.21503249 O.26228129 O.49933047