Cochlear Implants
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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Feb 26, 2026
Galderma Secures Triple Approval for Its New Cutting-Edge Restylane® Syringe Across the European Union, United States, and Canada; 4WEB Medical Secures FDA 510(k) Clearance for New SI Joint Truss System; Medtronic Debuts MiniMed Go Smart Insulin-Delivery System Featuring Simplera Sensor in the EMEA Region; Olympus Expands Labeling to Include Pediatric Use for Two Single-Use Bronchoscopes; Neurent Medical Reports Positive Randomized Controlled Trial Outcomes for the NEUROMARK® System; Envoy Medical Approaches Final Enrollment Phase for Its Fully Implanted Acclaim Cochlear Implant Trial
Galderma Announced Triple Approval of new state-of-the-art Restylane® Syringe in the EU, the U.S., and Canada, Reaffirming the Company’s Position at the Forefront of Injectable Aesthetics On February 25, 2026, Galderma announced that regulatory authorities in the EU, the U.S., and Canada had approved a new...
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Feb 19, 2026
Medtronic Wins FDA Green Light for Stealth AXiS; Retia Medical Secures FDA 510(k) Clearance for Argos Infinity; Danaher Announces Plan to Acquire Masimo Corporation; Dynarex Introduces New Advanced Negative Pressure Therapy Device; Valcare Medical Reports First U.S. Transseptal AMEND™ Implant in Early Feasibility Study; Envoy Medical Reports Enrollment Nearly Complete for Acclaim Cochlear Implant Pivotal Trial
Medtronic Received FDA Clearance for Stealth AXiS™ Surgical System, First Integrated Planning, Navigation and Robotics Platform for Spine Surgery On February 13, 2026, Medtronic, a global leader in healthcare technology, announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical sy...
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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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Nov 20, 2025
Zimmer Biomet Secures FDA Clearance for Upgraded ROSA® Knee Robotic System; IceCure’s ProSense® Cryoablation Platform Secures Swissmedic Approval for Use in Breast, Lung, Liver, and Kidney Tumors; Clairity Secures $43M Series B to Launch FDA-Authorized AI Platform for Breast Cancer Risk Prediction; Distalmotion Secures $150M to Boost U.S. Rollout of DEXTER® Robotic Surgery System; Envoy Medical Reaches Six-Month Benchmark with First 10 Patients in Acclaim® Cochlear Implant Trial; Cardiovalve Seeks CE Approval After Positive TARGET Study Results
Zimmer Biomet Received U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology On November 14, 2025, Zimmer Biomet Holdings, Inc., a leading global medical technology company, announced that its enhanced ROSA® Knee with OptimiZe™ system received 510(k) clearance from the U.S. Food and Drug...
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Oct 09, 2025
Vektor Medical Receives CE Mark for vMap; Tosoh’s GR01 HbA1c Analyzer Gains FDA 510(k) Clearance; Zimmer Biomet Acquires Monogram Technologies; Olympus Partners with W. L. Gore & Associates to Distribute GORE® VIABIL® Biliary Stent Globally; Medtronic Launches U.S. IDE Study on Hugo™ Robotic Surgery System for Gynecology; Envoy Medical Secures FDA Clearance to Advance Pivotal Trial to Final Stage Following Promising Three-Month Results
Vektor Medical Secures CE Mark for vMap, Bringing the Benefits of Non-Invasive Arrhythmia Mapping to Europe On October 7, 2025, Vektor Medical, a leading innovator in cardiac arrhythmia care, received CE Mark approval for its vMap® System, a non-invasive, AI-powered technology that converts standard 12-lea...
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Oct 02, 2025
Zimmer Biomet Secures Japan PMDA Approval for First Iodine-Treated Total Hip Replacement System; FluidAI Medical’s Origin™ Earns FDA 510(k) Clearance; Sky Labs Introduces CART BP; Forward Science Collaborates with Sage Dental to Launch PerioStōm; iotaMotion Sets New Benchmark with 1,000+ Cochlear Implant Procedures Using iotaSOFT®; Relief Cardiovascular Completes First Human Implant of Pioneering Smart Valve for Heart Failure Congestion
Zimmer Biomet Announced Japan PMDA Approval of World's First Iodine-Treated Total Hip Replacement System On September 25, 2025, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced that Japan’s Pharmaceutical and Medical Devices Agency (PMDA) had approved the iTaperloc® Complete a...
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Jul 10, 2025
Intuitive’s da Vinci 5 Gets CE Mark; Boston Scientific’s FARAPULSE™ Secures Expanded FDA Approval; Trividia Health’s TRUE METRIX® Added to Pennsylvania Medicaid List; Cerapedics’ PearlMatrix™ Sees First U.S. Clinical Use Post-FDA Nod; Smith+Nephew Expands Q-FIX◊ with Knotless Option; Cochlear Unveils World’s First Smart Cochlear Implant
Intuitive’s da Vinci 5 Surgical System Received CE Mark On July 02, 2025, Intuitive, widely recognized as a pioneer in robotic-assisted surgery and minimally invasive care, announced that its latest system, the da Vinci 5, had secured CE mark approval for use in both adult and pediatric patients across Eur...
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Jun 12, 2025
Samsung Galaxy Watch Sleep Apnea Feature Cleared for Europe With CE Certification; ZEISS CLARUS 700 Gains NMPA Approval in China; Envoy Medical’s Acclaim® Cochlear Implant Trial Progresses as Planned Following First Month Follow-Up; Masimo SedLine® Shown to Enhance Brain Monitoring Accuracy in Pediatric Anesthesia; Penumbra Launches Ruby® XL System; Johnson & Johnson Introduces the ETHICON™ 4000 Stapler
Samsung Expands Global Reach of Sleep Apnea Feature on Galaxy Watch With CE Marking Certification in Europe On June 5, 2025, Samsung Electronics Co., Ltd. announced the expanded global availability of its Sleep Apnea feature on the Galaxy Watch series, accessible through the Samsung Health Monitor app. The...
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