Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Abbott Secures CE Mark for Volt™ Pulsed Field Ablation System and Unveils TRILUMINATE™ Trial Data on TriClip™ for Tricuspid Valve Repair; Zimmer Biomet’s RibFix Advantage® Fixation System Earns CE Mark; Teleflex Announces Initial Clinical Data from IDE Study Evaluating Ringer™ PBC in Coronary Perforation Treatment; GE HealthCare Launches Revolution™ Vibe CT, Bringing Unlimited One-Beat Cardiac Imaging and AI Solutions; TELA Bio Launches Larger OviTex® PRS Sizes in the U.S.

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Sanofi’s Qfitlia Becomes First FDA-Approved Therapy for Hemophilia A or B; FDA Approves AstraZeneca’s IMFINZI as First Perioperative Immunotherapy for Bladder Cancer; Beam Therapeutics’ BEAM-302 for AATD Receives FDA Clearance; AstraZeneca’s CALQUENCE Combo Greenlit in EU for Mantle Cell Lymphoma; Ionis’ WAINZUA Wins EU Approval for Hereditary Transthyretin Amyloidosis

medtech-news-of-alcon-abbott-okami

Alcon Gains CE Mark for Clareon Vivity IOL in Europe; MicroPort MedBot’s Toumai SP Robot Wins NMPA Approval; Abbott Launches Intravascular Lithotripsy Trial; BD Advances GalaFLEX LITE™ Clinical Trial; GE HealthCare Unveils AI-Powered Invenia ABUS Premium; Okami Medical Introduces SENDERO® MAX Catheter

pharma-news-for-telix-​merck-alnylam

Clover’s SCB-1019 RSV Revaccination Study Clears U.S. IND; FDA Approves AMVUTTRA for ATTR-CM CV Risk Reduction; Pembrolizumab Combo Greenlit for HER2+ Gastric/GEJ Cancer; TREMFYA Becomes First IL-23 Inhibitor Approved for Crohn’s; FDA OKs GOZELLIX for Prostate Cancer Imaging

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-alexion-encell-sydnexis

FDA Expands SOLIRIS for Pediatric Myasthenia Gravis; vTv’s Cadisegliatin Program Resumes as FDA Lifts Hold; ENCell’s EN001 Wins Orphan Drug Designation for Charcot-Marie-Tooth; FDA Accepts Sydnexis’ NDA for SYD-101 in Pediatric Myopia; Cambium Bio’s Potency Assay Strategy Cleared for Elate Ocular Phase III Trials

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Caristo Wins FDA Clearance for AI Solution to Prevent Heart Attacks; Lindus Health and Sooma Medical Announce Key Clinical Trial for MDD Device; GT Metabolic Secures FDA Clearance for Expanded 50mm MagDI System; Beckman Coulter’s DxC 500i Integrated Analyzer Earns FDA Clearance for Enhanced Diagnostics

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

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ABANZA Secures FDA 510(k) Clearance for WasherCap™ Mini; Cerus Corporation Secures CE Mark for Next-Gen INTERCEPT Illumination Device; Spinal Stabilization Technologies Enrolls First U.S. Patient in IDE Trial for PerQdisc™; Inspira Technologies Reports Positive Clinical Results for AI-Integrated HYLA Blood Sensor; iCAD and RamSoft Partner to Expand ProFound AI Mammography Solutions in North America; Pulnovo Medical Secures Nearly $100M in Series C Funding

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PRGN-2012 Wins Priority Review for Recurrent Respiratory Papillomatosis; PYX-201 Granted Fast Track for R/M HNSCC; AJA001 IND Cleared for Autism Spectrum Disorder; LAE120 IND Approved for Advanced Solid Tumors; Relacorilant NDA Accepted for Hypercortisolism Treatment

medtech-news-for-medtronic-biomerica-alcon

Medtronic Secures FDA Approval for First-Ever Adaptive Deep Brain Stimulation System for Parkinson’s; FDA Grants Breakthrough Device Designation to Averto Medical’s ColoSeal™ System; Biomerica’s inFoods® IBS clinical trial findings were published in Gastroenterology; Lungpacer Medical’s STIMULUS Trial Highlights Improved Hemodynamics With Diaphragm Neurostimulation; Alcon Introduces Voyager DSLT; Stryker Finalizes Acquisition of Inari Medical

pharma-news-for-signet-bavarian-indivior

CTEXLI Approved for Cerebrotendinous Xanthomatosis; SIGX1094 Wins Fast Track for Diffuse Gastric Cancer; Bavarian Nordic’s Chikungunya Vaccine Cleared for Ages 12+; UX111 Gene Therapy Gains Priority Review for Sanfilippo Syndrome; SUBLOCADE Label Update Approved

medtech-news-for-clearpoint-neuro-volta-medical-whiteswell

FDA Grants 510(k) Clearance to Neonav® ECG Tip Location System; ClearPoint Neuro Secures EU MDR Certification for SmartFlow Cannula; Volta Medical’s AI-Driven Ablation Procedure Improves Outcomes in Persistent Atrial Fibrillation Trial; WhiteSwell Presents New Clinical Data on eLym System for Acute Heart Failure Treatment; J&J MedTech Introduces CEREGLIDE™ 92 Catheter System; Thermo Fisher Launches New Spatial Imaging System for Tissue Proteomics

pharma-news-for-galderma-gsk-astellas

EU Approves Galderma’s NEMLUVIO for Atopic Dermatitis and Prurigo Nodularis; GSK’s Penmenvy Wins FDA Nod; Ono Pharmaceuticals’ ROMVIMZA Gets Green Light from FDA for Symptomatic TGCT; Bristol Myers Squibb Updates on RELATIVITY-098 Phase III Trial Findings; FDA Expands Label for Astellas’ IZERVAY in Geographic Atrophy Treatment

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Agiliti Launches Essentia; KUBTEC Introduces PICASSO Plus; FDA Clears Neuvotion’s NeuStim™ for Non-Invasive Hand Stimulation in Stroke & SCI Patients; Ibex Medical Analytics Achieves Milestone with FDA 510(k) Clearance; BlueWind Medical Reports Strong Two-Year Outcomes for Revi® System in Peer-Reviewed Study; Reprieve Cardiovascular’s FASTR Pilot Trial Shows Positive Outcomes, FDA Approves IDE for Next Phase

pharma-news-for-biodexa-abbvie-insmed

Immix Bio’s NXC-201 Gets FDA RMAT for AL Amyloidosis; Biodexa’s eRapa Wins Fast Track for Familial Adenomatous Polyposis; AbbVie’s EMBLAVEO Approved for Complicated Intra-Abdominal Infections; Insmed’s Brensocatib Gains Priority Review for Bronchiectasis; Aro Bio’s ABX1100 IND Cleared for Pompe Disease

medtech-news-for-bioretec-honeynaps-aspen

Bioretec Ltd. Gains CE Mark for RemeOs™ Trauma Screw; HoneyNaps’ AI Sleep Diagnostic Software Achieves Recognition as the 73rd and 74th Innovative Medical Devices by South Korea’s MFDS; Movano Health Advances Clinical Trials for Innovative Non-Cuff Blood Pressure Monitor; IRB Approves PathMaker Neurosystems’ MyoRegulator® ALS Study; Aspen Medical Products Closes Deal to Acquire Advanced Orthopaedics; Surmodics Achieves Early Clinical Success with Pounce™ XL Thrombectomy System

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