Peripheral Vascular Devices
Jan 08, 2026
Gore Secures FDA Approval for Its First Deep Venous Stent for IVC and Iliofemoral Veins; Stereotaxis Secures FDA Approval for MAGiC Ablation Catheter; Stimlabs® LLC Announces FDA 510(k) Clearance and Launch of Allacor P™ for Wound Care; CorePlus and AIxMED Join Forces to Deliver AI-Powered Bladder Cancer Detection with Complete QC; Interim Clinical Outcomes at Six Months from the SPARTAN Study Evaluating the TransLoc 3D™ System; TYBR Health Reports First U.S. Clinical Use of the B3 GEL™ System
Gore Gained FDA Approval for First Deep Venous Stent Indicated for the IVC and Iliofemoral Veins On January 06, 2026, W. L. Gore & Associates’ medical business (Gore) announced that it had received FDA approval for the GORE® VIABAHN® FORTEGRA Venous Stent, formerly known as the GORE® VIAFORT Vascular S...
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Nov 13, 2025
Nitinotes Obtains CE Mark Approval for EndoZip™ System; FDA Grants 510(k) for Meduloc’s Innovative Fixation Solution for Small and Long Bones; Kaneka Launches i-ED COIL™ in Europe; Motive Health Unveils New At-Home Therapy for Lower Back Relief; Gore Reports Strong 12-Month Results for VIABAHN® FORTEGRA Venous Stent in Iliocaval Disease; Vexev Marks Completion of Enrollment in AV Fistula Mapping Clinical Study
Nitinotes Received CE Mark Approval of EndoZip™, the First Fully Automated Suturing System for Endoscopic Sleeve Gastroplasty On November 06, 2025, Nitinotes Ltd., a medical device company focused on transforming obesity treatment, announced that it had received CE Mark approval for its EndoZip™ System, th...
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Nov 06, 2025
Nexalin Technology Secures Israeli Regulatory Clearance for Gen-2 SYNC 15 mA DIFS™ Neurostimulation System; W&H Medical Launches First U.S.–Cleared Piezo & Drill Combo Console for Rhinoplasty & Facial Surgery; Elevaris Launches CDMO Services and Procedural Needle Offerings in EMEA; Cardinal Health Successfully Acquired Solaris Health; 4WEB Medical Sets a New Standard in Implant-Based Therapy; BD Reaches Key Milestone in AGILITY Trial Evaluating Revello™ Vascular Covered Stent for PAD
Nexalin Technology Announced Regulatory Approval to Sell Gen 2 SYNC, 15 mA Neurostimulation DIFS™ Device in Israel On October 30, 2025, Nexalin Technology, Inc., a company recognized for its Deep Intracranial Frequency Stimulation (DIFS™) technology, announced that its Gen-2 Console (“SYNC”) 15 mA neurosti...
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Jul 24, 2025
Medtronic Gains CE Mark for MiniMed™ 780G, Begins Onyx™ IDE Study; FDA Clears RIVANNA’s AI Ultrasound Guidance Platform; BD Launches First Clinical Trial with Libertas™ Wearable Injector; Olympus Debuts EU-ME3 Ultrasound Processor in U.S.; Thermo Fisher & Sanofi Expand U.S. Drug Manufacturing Partnership
Medtronic Secured CE Mark Approval for its Minimed™ 780G System, Extending its use to Insulin-Requiring Individuals With Diabetes, Including Children as Young as two Years old, Pregnant Women, and Patients with Type 2 Diabetes On July 21, 2025, Medtronic plc., a global medical technology leader, secured th...
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Jun 05, 2025
Guardant Health’s Shield Test Earns FDA Breakthrough Device Status; Reflow Medical Gains FDA De Novo Clearance for Spur Peripheral Stent System; FastWave Medical Achieves First-in-Human Use of Coronary Laser IVL System; BD Initiates Patient Registry to Assess Rotarex™ System in PAD Treatment; Johnson & Johnson Unveiled the KINCISE™ 2 System for Use in Knee and Hip Revision Surgeries; Cardinal Health Launches Single-Device Solution for Real-Time Tracking of Three Vital Signs
Guardant Health Secured FDA Breakthrough Device Designation for Its Shield Multi-Cancer Detection Test On June 03, 2025, Guardant Health, Inc., a precision oncology company, reported that the U.S. Food and Drug Administration (FDA) granted breakthrough device designation to its Shield multi-cancer detectio...
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Jul 28, 2022
AbbVie & iSTAR’S Strategic Alliance; Baxter Launches Welch Allyn RetinaVue 100 Imager PRO; Instylla’S Embrace Hydrogel Embolic System; Primary Endpoint Met in the RADIANCE II US Trial; Roche’s Elecsys Amyloid Plasma Panel; EU Approval to Seegene’s Allplex; SARS-CoV-2/FluA/FluB/RSV Assay
ReCor Medical and Otsuka Medical Devices Announce Primary Endpoint Met in the RADIANCE II US Pivotal Trial of the Paradise™ System for the Treatment of Hypertension On July 26, 2022, ReCor Medical, Inc., a completely owned subsidiary of Otsuka Medical Devices Co., Ltd., with its headquarters in Palo Alto,...
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