Otolaryngology

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Leica Biosystems Expands Digital Pathology Portfolio with Multiple FDA Clearances; Bracco’s VueJect Ultrasound Contrast Delivery System Gains FDA and Health Canada Authorizations; Oticon Introduces Next-Generation Reveal Hearing Aid With AI; Zepto Life Technology Secures Up to $8.9 Million NIAID Award for Infectious Disease Liquid Biopsy Platform; Nitinotes Broadens EASE IDE Trial Network for EndoZip; FastWave Medical Secures FDA IDE Approval for Pivotal Artero Peripheral IVL Trial

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medtech-news-for-restore-robotics-medtronic-bebird

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

medtech-news-for-galderma-4web-medical-medtronic

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

medtech-news-for-medtronic-retia-medical-danaher

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

medtech-news-for-zimmer-biomet-icecure-clairity

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

medtech-news-for-oncohost-bd-oticon

OncoHost Granted New York State Lab Permit, Enabling PROphetNSCLC® Nationwide Access; Onkos Surgical’s ELEOS Proximal Tibia with NanoCept antibacterial surface receives FDA 510(k) clearance; BD’s Simplified At-Home HPV Test to Expand Cervical Cancer Screening Internationally; Oticon’s New Zeal™ Hearing Aid Delivers Discreet Style with Next-Gen AI Sound & Connectivity; Nyra Medical Launches First­-in-Human Trial of New Mitral Valve Repair System; Cordis Reveals 12-Month Outcomes from SELUTION SLR DEB Trial

pharma-news-for-roche-astrazeneca-replimune

FDA Approves Genentech’s GAZYVA for Lupus Nephritis; Glaukos’ EPIOXA Wins FDA Approval for Keratoconus Treatment; FDA Accepts Replimune’s RP1 BLA Resubmission for Advanced Melanoma; Cogent’s Bezuclastinib Earns FDA Breakthrough Therapy for SM-AHN; Amgen’s TEZSPIRE Gets FDA Nod for Chronic Rhinosinusitis with Nasal Polyps

medtech-news-for-vektor-medical-tosoh-zimmer-biomet

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

medtech-news-for-zimmer-biomet-sky-labs-fluidai-medical

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

medtech-news-for-intuitive-boston-scientific-cerapedics

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

medtech-news-for-samsung-masimo-penumbra

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

medtech-news-for-glucotrack-ge-healthcare-bd

Glucotrack Secures Ethical Approval for Extended Clinical Trial of Continuous Blood Glucose Monitor; GE HealthCare Announces FDA Approval for Pediatric Use of Optison and Launches New Ultra-premium 1.5T MRI System; Envoy Medical Advances to Final Stage Following Clinical Milestone; SeaStar Medical Hits Interim Enrollment Goal in NEUTRALIZE-AKI Trial; BD Unveils New Cell Analyzer Integrating Spectral and Real-Time Imaging Innovations

medtech-news-for-telix-revbio-insulet

Illuccix Receives Dutch Approval for PSMA-PET Imaging in Prostate Cancer; FDA Approves Valcare Medical’s Early Feasibility Study for Novel Amend™ Trans-Septal System; RevBio Launches Pivotal Clinical Trial in Europe for Dental Implant Stabilization; Insulet’s RADIANT Trial Highlights Improved Glycemic Outcomes with Omnipod® 5 Following Direct Transition; Envoy Medical Raises $10 Million to Drive Clinical Progress on Next-Gen Hearing Device; Vave Health Unveils World’s First Wireless Whole-Body Ultrasound with Single PZT Transducer

pharma-news-for-neurotech-capricor-celltrion

Neurotech’s ENCELTO Becomes First FDA-Approved Treatment for MacTel Type 2; Plus Therapeutics’ Rhenium Obisbemeda Gets FDA Orphan Status; Novo Nordisk Cuts WEGOVY to $499/Month; Capricor’s Deramiocel Wins FDA Priority Review; Celltrion’s OMLYCLO Becomes First Interchangeable XOLAIR Biosimilar

Pharma-news-for-autolus-unicycive-abbvie

AUCATZYL Approved for R/R B-ALL; FDA Accepts NDA for Unicycive’s Oxylanthanum Carbonate; AstraZeneca and Amgen Report Positive Results in Chronic Rhinosinusitis; Nipocalimab Granted Breakthrough Designation for Sjögren’s Disease; AbbVie’s Schizophrenia Drug Fails Phase Studies

Pharma-news-for-roche-johnson&johnson-regeneron

Johnson & Johnson’s TREMFYA Approved for Ulcerative Colitis; Roche’s Tecentriq Hybreza Approved as Subcutaneous Anti-PD-(L)1; OCREVUS ZUNOVO Receives Twice-a-Year Multiple Sclerosis Injection Approval; Lilly’s EBGLYSS Greenlit for Moderate-to-Severe Atopic Dermatitis; DUPIXENT Approved for Adolescents with Chronic Rhinosinusitis

Audiology Devices Market Analysis

Ears to the Future: Evaluating Key Advancements and Trends Driving the Audiology Devices Market Growth

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