medical device
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 14, 2026
Aurie Wins FDA De Novo Grant for Innovative Reusable Urinary Catheter Technology; Biozen Secures FDA Clearance for Calibration-Free Cuffless Blood Pressure Technology; plusOne® Expands Wellness Care Portfolio with New Menopause and Fertility-Friendly Lubricants; TrilliumBiO and Oncobit Introduce Advanced Uveal Melanoma Monitoring Solution in the U.S.; Renerva Announces First-in-Human Implant of PNM-CAP™ for Neuroma Pain; SonoClear AS Announces Completion of Clinical Enrollment for Breakthrough Device-Designated SonoClear® System
Aurie Received FDA De Novo Grant for First Automated Safely Reusable Intermittent Urinary Catheter System On 11 May 2026, Aurie announced that its Aurie Reusable No-Touch Intermittent Catheter System™ had received marketing authorization from the U.S. Food and Drug Administration (FDA) through the Class II De No...
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May 07, 2026
Multi4 Medical Gains CE Mark Approval for Office-Based Bladder Cancer Treatment; FX Shoulder Solutions Achieves FDA 510(k) Clearance for FX V135® Easytech Platform; Ortho Development Launches Commercial Rollout of Trivicta® Hip Stem; Clover Podiatry Expands Foot and Wound Care Services With New Advanced Healing Center; CLiMB Study Highlights Superior Sensitivity of HelioLiver™ Blood Test Versus Ultrasound in Detecting Early-Stage HCC; Aqua Medical Unveils Promising DDW 2026 Data Showing Sustained Insulin Elimination in Type 2 Diabetes Patients
Multi4 Medical Received CE Mark - Moves Bladder Cancer Treatment from Operating Room to Outpatient Setting On 05 May 2026, the CE mark enabled the Multi4 System to be commercialized across Europe and represented a major advancement in urologic cancer care. The system introduced the world’s first all-in-one instr...
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Apr 30, 2026
Olympus Secures FDA Clearance for POWERSEAL™ Open Extended Jaw Device; Abbott’s Ultreon™ 3.0 Receives FDA Clearance and CE Certification; LTS Broadens CDMO Capabilities with Ophthalmic Drug Delivery Expertise; BD Transforms Central Line Placement with Groundbreaking Technology; AI Models Deliver Up to 73% Fewer Genome Analysis Errors in New Research; Calidar Finishes Enrollment in First-in-Human Trial of 4D Mammography System
Olympus Received FDA Clearance for POWERSEAL™ Open Extended Jaw Device On 28 April 2026, Olympus Corporation announced that it had received 510(k) clearance from the U.S. Food and Drug Administration for its POWERSEAL™ Open Extended Jaw Sealer/Divider for use in open surgical procedures. The approval marke...
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Apr 09, 2026
Waters Receives FDA Approval for Advanced HPV Self-Collection and Testing Kit; MedCAD Achieves FDA 510(k) Clearance for AccuStride® Tib/Fib Anatomical Solution; Mercy Medical Center Expands IBD Care with Office-Based Intestinal Ultrasound; BD Introduced Next-Generation TIPS Innovation to Enhance Portal Hypertension Care in the European Union; KingstronBio Completes First ProStyle M® Mitral Valve Implant in Confirmatory Trial; MiRus Launches Enrollment for STAR Randomized Study of Siegel™ TAVR System
Waters Announced the FDA Clearance of the Most Comprehensive At-Home Cervical Cancer Screening Tool, the Onclarity HPV Self-Collection Kit and FDA-Approved HPV Assay On 08 April 2026, Waters Corporation announced that the U.S. Food and Drug Administration had cleared the Onclarity HPV Self-Collection Kit and app...
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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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Mar 26, 2026
LiviWell Receives FDA Clearance for Livi, Pioneering Post-Intercourse Vaginal Care; Medtronic Advances Spine and Cardiac Care with ViaVerte Partnership and FDA Approval of OmniaSecure Lead; ZEISS Broadens Its Ophthalmic Workflow Portfolio in Canada; Starlight Cardiovascular Reports First-Ever Infant Treated with Lifeline Stent System at Cincinnati Children’s Hospital; Belay Diagnostics Highlights 82% Clinical Impact Rate for Summit™ and Vantage™ in CNS Lymphoma
LiviWell Secured FDA Clearance for Livi, Introducing a New Category in Post-Intercourse Vaginal Care On 24 March 2026, LiviWell announced that the U.S. Food and Drug Administration had granted clearance for Livi, a novel device developed to support vaginal health by absorbing semen and other post-intercour...
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Mar 19, 2026
MiniMed Secures FDA Clearance for MiniMed Flex; Spinal Elements Expands Portfolio with FDA-Cleared Ventana® Platform and Initial ALIF Launch; Mindray North America Strengthens Respiratory Care Offering Through Ventilator Market Entry; Micro-Tech Endoscopy Enters Definitive Deal to Acquire Key GI Product Lines from CONMED; Composite Manufacturing Inc. Unveils Study Showing NekSpine® Exoskeleton Eases Neck and Back Load During Simulated Surgeries; SkinVision Partners on Landmark Trial to Expand Dermatology Care Access in the U.S.
MiniMed Announced the FDA Clearance of MiniMed Flex™, the Company's Smallest Insulin Pump Featuring its First Smartphone-Controlled Design On 18 March 2026, MiniMed announced that it had received clearance from the U.S. Food and Drug Administration (FDA) for its MiniMed Flex™, a next-generation, discreet i...
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Mar 12, 2026
QT Imaging Secures FDA Clearance for Enhanced Breast Acoustic CT Scanner Configuration; LifeVac Secures FDA Authorization as the First and Only Anti-Choking Device; Smith+Nephew Introduces Next-Generation ALLEVYN COMPLETE CARE Foam Dressing for Enhanced Wound Management; Olympus Corporation Debuts Next-Gen Surgical Visualization Platform in the U.S.; IceCure Medical Receives FDA Approval for Post-Marketing ‘CHOICE’ Study of ProSense Cryoablation System; Envoy Medical Concludes Enrollment for Landmark Trial of Fully Implanted Cochlear Implant
QT Imaging Received FDA Clearance for its Breast Acoustic CT Scanner Enhanced Configuration to Improve Posterior Breast Imaging Coverage On 10 March 2026, QT Imaging Holdings, Inc., a medical device company focused on advancing breast health management through innovative radiation-free imaging technology, ...
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