Medical Devices

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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

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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

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Top Home-Use Medical Devices Every Household Should Consider

medtech-news-for-edwards-lifesciences-stimlabs-ngd-infection-prevention

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

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Spondylolisthesis Medical Devices: Advancing Care Through Innovation

parenteral-nutrition-in-healthcare

Parenteral Nutrition: A High-Growth Lifeline in Clinical Nutrition

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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

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BD Broadens BD MAX™ System Menu with IVDR-Certified VIASURE Assays; OrthAlign Broadens the Lantern® Hip Platform for Posterior Approach Total Hip Arthroplasty; Bioretec Received FDA Breakthrough Device Designation for the Remeos™ Drillpin; Medivis Achieves First FDA Authorization for AR Navigation in Neurosurgery; Cerapedics Publishes 24-Month ASPIRE Clinical Outcomes in Spine Journal; Acumed’s Acu-Loc NEXT System Debuts in First Wrist Fixation Surgery at Duke University Hospital

ai-driven-medical-imaging

The Automated Eye: How AI-Driven Diagnostics are Reshaping the Future of Medical Imaging

medtech-news-for-bendit-proverum-medint

Bendit Received FDA Clearance for the Bendit17™ Steerable Microcatheter; ProVee System Receives FDA Approval as a New-Era Prostatic Urethral Stent for BPH; a2z Radiology AI Secures $4.5M Seed Funding to Advance Full-Spectrum CT Analysis; MedINT Introduces Advanced Medical AI System Integrating Clinician Oversight; Nitinotes Treats First Patient in Pivotal EASE™ Trial of the EndoZip™ Automated Suturing System for ESG; Airiver Medical Secures FDA IDE Authorization to Launch Pivotal CRS Clinical Trial

energy-based-aesthetic-device-applications

A New Era of Dermatology: In-Depth Analysis of Energy-Based Aesthetic Device Applications

role-of-epilepsy-monitoring-devices

Epilepsy Monitoring Devices: Transforming Patient Care and Seizure Management

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Bracco Receives FDA Clearance for Additional Clinical Use of Max 3™ Syringeless MR Injector; RapidAI Broadens Clinical AI Portfolio with Five Newly Granted FDA Clearances; Ceribell Secures FDA 510(k) Clearance for Clarity® Algorithm in Neonatal Care; BD Introduces Surgiphor™ Irrigation System Across Europe to Enhance Surgical Patient Protection; Neurophet and The Florey Announce Strengthened Collaboration to Advance Alzheimer’s Diagnostic Solutions; VSI® Performs First-Ever Robotic Minimally Invasive Bertolotti’s Resection; BioWave® Demonstrates Safe and Effective Home-Based and War Injury Pain Relief in Latest Clinical Data

role-of-bioanalytical-testing-services

Bioanalytical Testing Services: Advancing Drug Development and Precision Medicine

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

neuroprotective-devices-assessment

Neuroprotection Devices: Advancing Brain Protection Through Medical Innovation

medtech-news-for-nitinotes-meduloc-kaneka

Nitinotes Obtains CE Mark Approval for EndoZip™ System; FDA Grants 510(k) for Meduloc’s Innovative Fixation Solution for Small and Long Bones; Kaneka Launches i-ED COIL™ in Europe; Motive Health Unveils New At-Home Therapy for Lower Back Relief; Gore Reports Strong 12-Month Results for VIABAHN® FORTEGRA Venous Stent in Iliocaval Disease; Vexev Marks Completion of Enrollment in AV Fistula Mapping Clinical Study

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