MedTech Market
May 21, 2026
Leo Cancer Care Receives CE Mark Approval for Marie® Upright Radiotherapy System; PorTal Access, Inc. Hits Critical Regulatory Benchmark with Flexi-Port™ 510(k) Submission; Araceli Biosciences Introduces Endeavor® Live Cell to Accelerate AI-Driven Drug Discovery Imaging; TrilliumBiO Partners with Oncobit to Launch Next-Generation Uveal Melanoma Monitoring Platform; Advita Ortho Reports First Clinical Application of Equinoxe® Scapula Reconstruction System; Implantica Announces Findings Supporting RefluxStop®’s Economic Advantage in GERD Treatment in Italy
Leo Cancer Care Secured CE Mark for Marie®, Advancing Upright Radiotherapy in Europe On 21 May 2026, Leo Cancer Care announced that its flagship upright radiotherapy system, Marie, had received CE marking approval, enabling commercial deployment across Europe. The approval marked a significant advancement ...
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Apr 23, 2026
Utepreva Announces FDA 510(k) Clearance for Endometrial Sampler Aimed at Early Cancer Detection; Sonorous Neurovascular Announces FDA 510(k) Clearance of BosCATH Neurovascular Catheter; OrganaBio and RxMP Therapeutics Partner to Support Manufacturing of RMP-402 Hemostatic Therapy; RhythMedix Introduces the New RhythmStar® SL Advanced Cardiac Monitor; Nicklaus Children’s Hospital Achieves First Traveling Bedside PDA Closure in Fort Lauderdale NICU; RIVANNA Advances Multi-center Clinical Study of Accuro XV Musculoskeletal Imaging System
Utepreva Introduced FDA 510(k)-Cleared Endometrial Sampler Designed to Support Early Detection of Endometrial Cancer On 22 April 2026, Utepreva LLC announced the launch of the Utepreva Endometrial Sampler, a patented, FDA 510(k)-cleared, single-use endometrial sampling device designed to enhance tissue capture a...
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Apr 16, 2026
Reach Surgical Announces CE Mark Certification for Innovative iREACH IRIS Stapling System; TOBY Earns FDA Breakthrough Tag for Innovative Urine-Based Cancer Detection Test; DuPont Introduces AmberChrom™ XT SL Resins to Streamline Biopharma Processing; Sectra Strengthens AI Roadmap with Completion of Oxipit Acquisition; KingstronBio Marks First Patient Implant of ProStyle M® in National Multicenter Study; MiRus Starts Recruiting Patients for STAR Trial Evaluating Siegel™ Valve
Reach Surgical Received CE Mark Approval for iREACH IRIS, First Powered Reusable Stapler with Real-Time Firing Curve™ and 90° Articulation On 14 April 2026, Reach Surgical, the surgical solutions division of Genesis MedTech, received CE Mark approval for its next-generation powered stapling platform, iREACH IRIS...
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Apr 02, 2026
Restore Robotics Secures FDA 510(k) Clearance for Two New da Vinci Xi® Instruments; Medtronic Wins FDA Approval for OmniaSecure™ Defibrillation Lead Enabling Conduction System Pacing; Bebird Introduces EarSight Ultra; BD Introduces AI-Driven Medication Dispensing System in Europe; i-Lumen Scientific Secures FDA IDE Approval to Launch U.S. Enrollment for i-SIGHT2 Dry AMD Trial; Belay Diagnostics Highlights 82% Clinical Impact Rate in CNS Lymphoma Evaluation
Restore Robotics Received FDA 510(k) Clearance for Two Additional da Vinci Xi® Robotic Instruments On 31 March 2026, Restore Robotics announced that it had received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the remanufacturing of two more da Vinci Xi robotic surgic...
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Jan 29, 2026
Seno Medical Secures EU MDR CE Mark for Next-Generation Imagio® Imaging System; Spine Innovation Announces FDA 510(k) Clearance of LOGIC™ Titanium Expandable Interbody System; Laborie Adds JADA® System to Obstetrics Portfolio for Rapid PPH Control; Olympus Introduces SecureFlex™ Single-Use Fine Needle Biopsy Device in the U.S.; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; Myra Vision Begins U.S. ADAPT Glaucoma Study, Treating First Participant
Seno Medical’s Next-Generation Imagio® Imaging System Obtained European Union (EU) Medical Device Regulation (MDR) CE Mark Certification On January 26, 2026, Seno Medical received CE Mark certification for its next-generation Imagio® Imaging System, Model 9100, confirming that the device met the stringent ...
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Jan 22, 2026
Sonomotion Secures FDA Clearance for Break Wave™ Lithotripsy System; Aidoc Earns FDA Clearance for Comprehensive AI Foundation Model in Healthcare; BD and Ypsomed Deepen Partnership to Serve Expanding Biologics Market; Omnia Medical Launches FDA-Approved PsiF DNA™ System to Market; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; NEURO PMR Data Validates Hyperfine’s Diagnostic Precision and Patient-Centered Care
Sonomotion Announced FDA Clearance for its Break Wave™ Lithotripsy Device for Treatment of Kidney Stones On January 21, 2026, SonoMotion, a venture-backed medical device company focused on developing non-invasive solutions for kidney stone treatment, announced that it had received U.S. Food and Drug Admini...
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Jan 15, 2026
Medtronic Diabetes Secures FDA Clearance for MiniMed Go™ Smart MDI Platform; Neurolief Achieves FDA PMA Approval for Novel At-Home Brain Stimulation Therapy for Depression; Haemonetics Completes Acquisition of Vivasure Medical Limited; Boston Scientific Enters Agreement to Acquire Valencia Technologies; Butterfly Medical Completes Pivotal Trial for Minimally Invasive BPH Therapy; TYBR Health Announces First U.S. Clinical Use of the B3 GEL™ System
Medtronic Diabetes Announced FDA Clearance for MiniMed Go™ Smart MDI System Featuring Instinct Sensor Made by Abbott On January 12, 2026, Medtronic, a global leader in healthcare technology, announced that it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MiniMed Go™ app. The MiniM...
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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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Jan 01, 2026
Edwards Lifesciences Receives FDA Approval for SAPIEN M3 Mitral Valve System; StimLabs Secures FDA Clearance for Theracor™, an Umbilical Cord–Derived Medical Device Sheet; NGD Infection Prevention Installs NGD200 System at the Middle East’s Largest Medical Center; Overture Orthopaedics Reaches $1.0M Sales Milestone for OvertureTi® Knee Resurfacing System; Envoy Medical Achieves Enrollment Milestone in Pivotal Trial of Fully Implanted Acclaim® Cochlear Implant; Galaxy Therapeutics Announces Completion of Patient Enrollment in Pivotal SEAL-IT IDE Trial
FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy On December 23, 2025, Edwards Lifesciences announced that its SAPIEN M3 mitral valve replacement system, the first transcatheter therapy using a transseptal approach, received approval from the...
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Dec 24, 2025
Johnson & Johnson Secures FDA Approval for TRUFILL® n-BCA in Chronic Subdural Hematoma Treatment; Abbott’s Volt™ Pulsed Field Ablation System Gains FDA Approval for AF Patients; Medicus Pharma Ltd. Partners with Reliant AI to Develop an Artificial Intelligence–Driven Clinical Data Analytics Platform; Solventum Finalized the Acquisition of Acera Surgical; Envoy Medical Hits Critical Enrollment Benchmark in Acclaim® Cochlear Implant Pivotal Trial; Galaxy Therapeutics Completes Enrollment in Pivotal SEAL IT IDE Study
Johnson & Johnson Received FDA Approval for TRUFILL n BCA Liquid Embolic System for the Treatment of Symptomatic Chronic Subdural Hematoma On December 18, 2025, Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and Drug Administration (FDA) had approved an expanded i...
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