Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Zimmer Biomet Wins FDA Breakthrough Status for Iodine-Treated Hip Implant; Terumo Gains U.S. Clearance for OPUSWAVE® System and DualView® Catheter; Medtronic’s Symplicity Spyral RDN Device Added to CMS National Coverage; West Launches Synchrony™ PFS System at CPHI; Emboline Completes U.S. Pivotal IDE Trial Enrollment for Emboliner® Device; Laborie Completes First Procedures in ENDURE 1 Trial with Optilume® Balloon

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Syndax Pharmaceuticals Receives FDA Approval for REVUFORJ; FDA Approves BLENREP for Adults with Relapsed/Refractory Multiple Myeloma; Novartis to Acquire Avidity for $12 Billion; BridgeBio Reports Positive Phase 3 Results for Small Molecule BBP-418 in LGMD2I/R9 FORTIFY Study; Eli Lilly to Acquire Adverum Biotechnologies

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-scanogen-lapsi-health-medtronic

Scanogen’s Bloodstream Infection Assay Earns FDA Breakthrough Device Status; Lapsi Health Launches Keikku 2.0; Medtronic BrainSense™ Adaptive DBS Earns 2025 TIME Best Inventions Honor; Photocure Partners with Intelligent Scopes Corporation to Advance AI Integration in Blue Light Cystoscopy; Conformal Medical Expands CONFORM Trial to Europe; Materna Medical Presents Study on At-Home Patient Outcomes: Experienced vs. Naïve Dilator Users

pharma-news-for-boehringer-denali-regeneron

FDA Approves Boehringer’s JASCAYD as First New IPF Therapy in Over a Decade; Denali Therapeutics’ Tividenofusp Alfa BLA Review for Hunter Syndrome Extended by FDA; Bicara’s Ficerafusp Alfa Earns FDA Breakthrough Tag for 1L HPV-Negative Head & Neck Cancer; BeOne Medicines’ Sonrotoclax Granted FDA Breakthrough Designation for Cancer Treatment; FDA Clears LIBTAYO for Adjuvant Use in Cutaneous Squamous Cell Carcinoma

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

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Aminex Therapeutics Secures FDA Orphan Drug Designation for AMXT 1501 + DFMO in Neuroblastoma; Eccogene Gets FDA Nod to Begin Phase IIa MOSAIC Trial of ECC4703 + ECC0509 in MASH; Orca Bio’s Orca-T Earns FDA Priority Review for Hematologic Malignancies; Alto Neuroscience Gains FDA Fast Track for ALTO-101 in Cognitive Impairment Linked to Schizophrenia; Taysha Gene Therapies Wins FDA Breakthrough Therapy Status for TSHA-102 in Rett Syndrome

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

pharma-news-for-regeneron-kedrion-crinetics

Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year; Eli Lilly’s INLURIYO Approved for ER+, HER2-, ESR1-Mutated Advanced Breast Cancer; Janssen’s TREMFYA Secures FDA Nod for Pediatric Plaque Psoriasis and Psoriatic Arthritis; Kedrion Biopharma’s QIVIGY Approved for Primary Humoral Immunodeficiency in Adults; Crinetics Pharma Wins FDA Approval for First Daily Pill, PALSONIFY, for Rare Growth Disorder

medtech-news-for-medtronic-virtuoso-surgical-lunit

Medtronic Gains FDA Clearance for Altaviva™ Device to Simplify Treatment of Urge Urinary Incontinence; FDA Grants Breakthrough Device Status to Virtuoso’s Surgical Robot; Lunit and Agilent Strike Partnership to Integrate AI into Biomarker-Based Diagnostics; QuidelOrtho Launches QUICKVUE Influenza + SARS Test for Clinical Use; Transpara® Breast AI Chosen to Power $16M PRISM Clinical Trial in the U.S.; IceCure Showcases ProSense® at CIRSE 2025 with Strong Clinical Evidence from 4 Independent Cryoablation Studies

pharma-news-for-merck-incyte-biocon

Merck Wins FDA Approval for KEYTRUDA QLEX for Subcutaneous Use in Adults With Solid Tumors; Incyte Gains FDA Nod for OPZELURA Cream in Children Aged 2–11 With Atopic Dermatitis; Minovia Therapeutics Receives FDA Fast Track Designation for MNV-201 in Myelodysplastic Syndrome; MavriX Bio Secures FDA Fast Track for MVX-220 Gene Therapy in Angelman Syndrome; Biocon Biologics Gets FDA Approval for Denosumab Biosimilars BOSAYA and AUKELSO

medtech-news-for-amber-implants-rejuva-fresh-ge-healthcare

Amber Implants Wins FDA 510(k) Clearance for VCFix® Spinal System; Merit Medical’s Embosphere Microspheres Receive CE Mark for Genicular Artery Embolisation in Knee OA; Rejuva Fresh® Introduces REVIVO™ Dual Summit 1927/1550 Fractional Laser System; GE HealthCare Eyes Acquisition of icometrix to Enhance Neurology Imaging and Brain MRI Assessment Tools; Diality Reports First Patient Dosed in Moda-flx Home IDE PRESCRIBE Trial; DUBSTENT DIABETES Trial Begins Enrollment: Aiming to Optimize PCI Outcomes in Patients with Diabetes

pharma-news-for-corstasis-amneal-greenwich

Lion TCR Secures Triple FDA Milestones with IND Clearance for Chronic Hepatitis B; Corstasis Therapeutics Wins FDA Approval for ENBUMYST Nasal Spray to Treat Edema in CHF, Liver, and Kidney Disease; Amneal Gains FDA Approval for Sodium Oxybate Oral Solution in Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness; Greenwich LifeSciences’ GLSI-100 Granted FDA Fast Track Designation; Akeso’s Ligufalimab Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia

medtech-news-for-onward-medical-fraiya-medtronic

ONWARD Medical’s ARC-EX System Gains CE Mark; Microbot Medical Secures FDA 510(k) Clearance for LIBERTY® Endovascular Robotic System; Fraiya Launches Major NHS Clinical Trial Using AI for Pregnancy Ultrasounds; Medtronic Hugo™ Robotic-assisted Surgery System in Hernia Repair Met Safety and Effectiveness Endpoints; Willow Launches Willow Wave, Pioneering a New Standard in Breastfeeding; Vivalink Launches New Adhesive to Improve Wearable ECG Performance

pharma-news-for-takeda-telix-boehringer

NeuroNOS’ BA-101 Granted FDA Orphan Drug Status for Glioblastoma; Takeda’s VONVENDI Approval Expanded for Von Willebrand Disease in Adults and Children; Telix Gains FDA Nod on Resubmission Pathway for TLX101-CDx NDA; Saol Therapeutics Receives FDA CRL for SL1009 in Pyruvate Dehydrogenase Complex Deficiency; FDA Grants Breakthrough Therapy Designation to Boehringer’s HERNEXEOS for HER2-Mutant Advanced NSCLC

medtech-news-for-geneseeq-technology-medtronic-corneat-vision

Geneseeq Technology Inc.’s GENESEEQPRIME® Assay Receives FDA 510(k) Clearance; Medtronic’s MiniMed™ 780G Gains FDA Approval for Abbott Instinct Sensor Integration and Type 2 Diabetes Use; CorNeat Vision’s Artificial Cornea Restores 20/20 Vision for Shingles-Induced Blindness; Johnson & Johnson Reports Favorable Outcomes from Real-World VARIPULSE™ PFA Study at 2025 ESC Congress; SprintRay Strengthens Dental 3D Printing Portfolio with EnvisionTEC Acquisition; Olympus Unveils Latest Imaging Platform for ENT and Urology in the U.S.

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