MedTech Market
Jul 16, 2026
POLYTECH Announced Regulatory Clearance for Improvements to the Microthane Process; ElectroWire Medical Earns 510(k) Clearance for LightningWire™ System; NeuroLexIQ Partners with Canary Speech to Introduce AI-Driven Voice Analysis for Injury Intake; BIOTRONIK Neuro Acquires Spinal Cord Stimulation Technology from Soin Neuroscience; Lakewood-Amedex Biotherapeutics Highlights Preclinical Safety Evidence Ahead of Nu-3 Gel Phase 2a Study; Cumulus Neuroscience Presents Evidence That Two-Minute Digital Test Enhances Alzheimer’s Trial Pre-enrichment
POLYTECH Announced the Approval of an Updated Process for Microthane® On 16 July 2026, POLYTECH Health & Aesthetics announced the approval of its updated proprietary manufacturing process for Microthane®, its polyurethane-coated breast implant technology. The company stated that the revised process was...
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Jul 02, 2026
STARMED Secures FDA 510(k) Clearance for Benign Thyroid Nodule Ablation; SciBase Advances U.S. Expansion with FDA 510(k) Submission for Nevisense; ALR Technologies to Acquire CGM Medical Technology in US$45 Million and 200 Million Share Deal; Co-Diagnostics Completes Validation Studies Ahead of FDA 510(k) Submission for Upper Respiratory Point-of-Care Test; Corvention Launches Innovative Balloon Catheter in the U.S. Following First Clinical Case; OrthAlign Reports First Clinical Cases Using Lantern® ASC System
STARMED Received FDA 510(k) Clearance for a Benign Thyroid Nodule Ablation Indication On 01 July 2026, STARMED America announced that it had received FDA 510(k) clearance for the first radiofrequency ablation (RFA) system in the United States specifically indicated for the treatment of benign thyroid nodules. Th...
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Jun 25, 2026
Legacy Expands Diagnostic Portfolio with New York CLEP Approval for Two LDTs; Quest Diagnostics Expands Patient Access to ctDNA MRD Testing with New York Approval of Haystack MRD; MVZ MedDiagnost and Sectra Ink 10-Year Deal to Unify Radiology Network Across 10 Sites; ALZpath and Abbott Enter Global Licensing Deal to Expand Blood-Based Alzheimer’s Diagnostics; Corvention Reaches Key Commercial Milestone with First U.S. Procedure and Balloon Catheter Launch; ZETA SURGICAL® Achieves First Clinical Milestone with Initial Patient Treatment at HOPE Therapeutics
Legacy Received New York State CLEP Approval for Two Laboratory-Developed Tests: Semen Analysis and DNA Fragmentation On 24 June 2026, Legacy announced that the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP), administered by the Wadsworth Center, had validated and approved it...
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Jun 11, 2026
Sibel Health Secures EU MDR CE Mark, Subtle Medical Wins FDA Clearance, Roche Acquires PathAI, Carestream Launches Lux HD Detectors, and New Clinical Milestones in Atopic Dermatitis & Carpal Tunnel Care
Sibel Health Received EU MDR Class IIb CE Mark for ANNE® One: The First Wireless Wearable Patient Monitoring Platform Certified to Key Interoperability Standards (Regulatory Update) On 10 June 2026, Sibel Health Inc., an award-winning medical technology company, announced that its ANNE® One system had receiv...
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May 28, 2026
FDA Grants Breakthrough Device Status to TOBY’s Urine Test for Alzheimer’s Detection; ubtle Medical Achieves FDA Clearance for Next-Gen SubtleHD™(PET) Software; Ernest Health Expands Rehabilitation Network Through Reunion Hospitals Deal; Olympus Expands Prostate Cancer Footprint Through BioProtect Acquisition; ABILITY Neurotech Secures IMDD Approval for Clinical Trial of Chronic Brain-Computer Interface Implantation in ALS Patients; Implantica Reports Strong Economic Benefits of RefluxStop® in Italian GERD Treatment Study
TOBY Received FDA Breakthrough Device Designation for Its Urine-Based Alzheimer's Disease Diagnostic Test On 26 May 2026, TOBY, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Device Designation to the TOBY Test for Alzheimer’s Disease. The designation recognized th...
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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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