Drug Eluting Balloons
Oct 30, 2025
Zimmer Biomet Wins FDA Breakthrough Status for Iodine-Treated Hip Implant; Terumo Gains U.S. Clearance for OPUSWAVE® System and DualView® Catheter; Medtronic’s Symplicity Spyral RDN Device Added to CMS National Coverage; West Launches Synchrony™ PFS System at CPHI; Emboline Completes U.S. Pivotal IDE Trial Enrollment for Emboliner® Device; Laborie Completes First Procedures in ENDURE 1 Trial with Optilume® Balloon
Zimmer Biomet Announced FDA Breakthrough Designation for World's First Iodine-Treated Total Hip Replacement System On October 28, 2025, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced that the FDA had granted breakthrough device designation for its groundbreaking iodine-treat...
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Oct 23, 2025
OncoHost Granted New York State Lab Permit, Enabling PROphetNSCLC® Nationwide Access; Onkos Surgical’s ELEOS Proximal Tibia with NanoCept antibacterial surface receives FDA 510(k) clearance; BD’s Simplified At-Home HPV Test to Expand Cervical Cancer Screening Internationally; Oticon’s New Zeal™ Hearing Aid Delivers Discreet Style with Next-Gen AI Sound & Connectivity; Nyra Medical Launches First-in-Human Trial of New Mitral Valve Repair System; Cordis Reveals 12-Month Outcomes from SELUTION SLR DEB Trial
OncoHost Received New York State Laboratory Permit, Expanding Availability of PROphetNSCLC® Precision Oncology Test On October 22, 2025, OncoHost, a technology company transforming the approach to precision medicine through plasma proteomics and AI, announced that it had received a laboratory permit from t...
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Sep 18, 2025
Amber Implants Wins FDA 510(k) Clearance for VCFix® Spinal System; Merit Medical’s Embosphere Microspheres Receive CE Mark for Genicular Artery Embolisation in Knee OA; Rejuva Fresh® Introduces REVIVO™ Dual Summit 1927/1550 Fractional Laser System; GE HealthCare Eyes Acquisition of icometrix to Enhance Neurology Imaging and Brain MRI Assessment Tools; Diality Reports First Patient Dosed in Moda-flx Home IDE PRESCRIBE Trial; DUBSTENT DIABETES Trial Begins Enrollment: Aiming to Optimize PCI Outcomes in Patients with Diabetes
Amber Implants Secured FDA 510(k) Clearance for VCFix® Spinal System: A Next-Generation Solution for Vertebral Compression Fractures On September 17, 2025, Amber Implants, a pioneering medical technology company focused on developing advanced solutions for spinal injuries, announced that it received cleara...
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Aug 07, 2025
SetPoint Medical Earns FDA Nod for First-of-Its-Kind Neuroimmune Modulation Therapy in RA; Body Vision Medical Secures Singapore Pre‑Market Approval for LungVision; BioLab Holdings Initiates Landmark Clinical Trial for Placental Membrane Therapies; Concept Medical Launches MAGICAL-SV IDE Trial; Frenova Enters Strategic Partnership to Push Boundaries in Kidney Precision Medicine; Demetra Acquires OrthoFundamentals and Establishes Global Spine Division
SetPoint Medical Received FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis On July 31, 2025, SetPoint Medical, a company focused on developing therapies for individuals with chronic autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) approved its Se...
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Apr 24, 2025
FDA Approves Simplera Sync™ Sensor for MiniMed™ 780G System; BVI Medical Secures FDA 510(k) Clearance for Leos™ Laser Endoscopy System in Ophthalmology; Surmodics Announces TRANSCEND Trial Data Supporting SurVeil™ Drug-Delivery Platform; Elutia Launches EluPro™ Registry Study to Gather Real-World Clinical Data; BD Launches Next-Generation AI-Driven Hemodynamic Monitoring and Industry-First Bioabsorbable Mesh for Umbilical Hernia Repair
New Simplera Sync™ Sensor for the MiniMed™ 780G System Secured FDA Approval, Advancing Insulin Delivery On April 18, 2025, Medtronic plc, a global leader in healthcare technology, received FDA approval for its Simplera Sync™ sensor for integration with the MiniMed™ 780G system. This approval enhances the f...
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Mar 07, 2024
Philips Teamed with SyntheticMR; BioPhotas’s Celluma Light Therapy; Boston Scientific’s AGENTTM Drug-Coated Balloon; Varian’s TrueBeam and Edge Radiotherapy Systems; Carthera’s Brain-Blood Barrier Trial; Prototype Device Effectively Treated Multiorgan Failure
Philips Teamed with SyntheticMR to Deliver Breakthrough AI-based Quantitative Brain Imaging in MR to Advance Neurology Care For Patients On March 01, 2024, Philips in collaboration with SyntheticMR announced the launch of Smart Quant Neuro 3D, a significant advancement in objective decision support for diag...
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