Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Guardant Health’s Shield Test Earns FDA Breakthrough Device Status; Reflow Medical Gains FDA De Novo Clearance for Spur Peripheral Stent System; FastWave Medical Achieves First-in-Human Use of Coronary Laser IVL System; BD Initiates Patient Registry to Assess Rotarex™ System in PAD Treatment; Johnson & Johnson Unveiled the KINCISE™ 2 System for Use in Knee and Hip Revision Surgeries; Cardinal Health Launches Single-Device Solution for Real-Time Tracking of Three Vital Signs

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Eli Lilly’s ZEPBOUND Surpasses WEGOVY in SURMOUNT-5 Trial; Verastem Oncology Secures FDA Approval for AVMAPKI + FAKZYNJA in KRAS-Mutant Ovarian Cancer; Thermosome Gains Orphan Drug Designation for THE001; Beam Therapeutics Receives RMAT Status for BEAM-302 in AATD; Capsida Biotherapeutics Gets IND Clearance for STXBP1 Gene Therapy

medtech-news-for-teleflex-livanova-roche

Teleflex Receives FDA 510(k) Clearance to Expand Use of QuikClot Control+™; Edwards Wins FDA Nod for TAVR Use in Asymptomatic Aortic Stenosis; LivaNova Announces Positive 12-Month Results from OSPREY Study in Moderate to Severe OSA; Lipogems Completes Final Patient Visit in ARISE 1 Knee Osteoarthritis Trial; Roche Launches Advanced Elecsys PRO-C3 Test for More Accurate Liver Fibrosis Grading; iRhythm Introduces Zio® Long-Term ECG Monitoring in Japan, Enhancing AI-Driven Arrhythmia Detection

artificial-intelligence-machine-learning-software-as-medical-device

Artificial Intelligence and Machine Learning in Software as a Medical Device (SaMD)

Abeona Secures FDA Nod for ZEVASKYN, the First Gene Therapy for RDEB; AbbVie Gains FDA Approval for RINVOQ in Giant Cell Arteritis; Lantern Pharma Advances LP-184 with IND Clearance for TNBC Trial; Ichnos Glenmark Earns FDA Fast Track for ISB 2001 in Multiple Myeloma; Rezolute Wins Breakthrough Therapy Designation for Ersodetug in Tumor-Induced Hypoglycemia

medtech-news-for-medtronic-roche-boston-scientific

Medtronic Receives FDA Approval for OmniaSecure™ Lumenless Defibrillation Lead and Presents Positive Clinical Trial Results for Hugo™ Robotic-Assisted Surgery System; Roche’s AI Companion Diagnostic for NSCLC Earns FDA Breakthrough Device Designation; Boston Scientific Announces Positive 12-Month Phase 2 Results from ADVANTAGE AF Trial of FARAPULSE™ PFA System; Bausch Health Launches Fraxel FTX™ to Advance Skin Rejuvenation Treatments; Gestalt Diagnostics Secures $7.5M in Series A to Scale AI Pathology Solutions

pharma-news-for-boston-scientific-roche-northstrive

Boston Scientific Pushes Forward Despite $200M Tariff Challenge; Northstrive Biosciences Gets FDA Green Light to Advance EL-22 Obesity Trial; Roche Acts Swiftly to Offset U.S. Tariff Impact with Global Engagements; Verastem Oncology Secures IND Clearance for KRAS G12D Inhibitor Trial; BlackfinBio Gets FDA OK for Phase I/II Trial of BFB-101 in SPG47

medtech-news-for-medtronic-elutia-bd

FDA Approves Simplera Sync™ Sensor for MiniMed™ 780G System; BVI Medical Secures FDA 510(k) Clearance for Leos™ Laser Endoscopy System in Ophthalmology; Surmodics Announces TRANSCEND Trial Data Supporting SurVeil™ Drug-Delivery Platform; Elutia Launches EluPro™ Registry Study to Gather Real-World Clinical Data; BD Launches Next-Generation AI-Driven Hemodynamic Monitoring and Industry-First Bioabsorbable Mesh for Umbilical Hernia Repair

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Exploring the Impact of AI in Mental Health: How it is Going to Revolutionize Diagnosis and Treatment for a Better Tomorrow?

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FDA Approves Sanofi/Regeneron’s DUPIXENT as First New CSU Therapy in Over a Decade; Gilead’s TRODELVY + KEYTRUDA Shows PFS Benefit in PD-L1+ TNBC; Tempest’s TPST-1495 Gets FDA Orphan Tag for FAP; uniQure’s AMT-130 Granted FDA Breakthrough for Huntington’s; NeuroNOS’ BA-102 Secures FDA Orphan Status for Phelan-McDermid Syndrome

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Edwards’ SAPIEN M3 Becomes First Transfemoral TMVR System to Receive CE Mark; Terumo Neuro Receives FDA Clearance for Carotid Stent System; Microbot Medical Reports Complete Robotic Navigation Success in LIBERTY® System Pivotal Trial; J&J MedTech Marks Milestone with First OTTAVA™ Robotic Surgeries; Baxter Introduces Room-Temperature Hemopatch for Faster Surgical Hemostasis; Merit Medical Introduces the Ventrax™ Delivery System

pharma-news-for-cellenkos-mirum-soleno

Cellenkos’ CK0801 Granted FDA Orphan Drug Status for Aplastic Anemia; Mirum’s LIVMARLI Gets FDA Nod for Tablet Formulation; SynOx’s Emactuzumab Earns FDA Fast Track for TGCT; Bristol Myers Squibb’s OPDIVO + YERVOY Combo Approved by FDA for First-Line Advanced Liver Cancer; Soleno Launches VYKAT XR, the First FDA-Approved Therapy for PWS-Related Hyperphagia

medtech-news-for-ventris-medical-orthocell-icu-medical

Ventris Medical Secures Additional FDA Clearance for Backpack® Bone Graft in Intervertebral Disc Applications; Orthocell Gains FDA 510(k) Clearance for Remplir™; ICU Medical Launches New Infusion Device Category with FDA-Cleared Plum Solo™ and Plum Duo™ IV Pumps; Anaconda Biomed Kicks Off U.S. Enrollment for ATHENA Trial Testing ANA Funnel Catheter in Stroke Care; OrthoPediatrics Expands Scoliosis Portfolio with Launch of Innovative VerteGlide™ System; 3D Systems Powers World’s First On-Site Facial Implant Manufacturing at Point-of-Care

Feature-AI-Driven Diagnostics_ Why are They the Next Big Thing in Healthcare

AI-Driven Diagnostics: Why are They the Next Big Thing in Healthcare?

pharma-news-for-amgen-novartis-biogen

Amgen’s UPLIZNA Wins First FDA Nod for IgG4-Related Disease; Aldeyra Gets FDA CRL for Reproxalap in Dry Eye; Novartis’ Vanrafia Snags Accelerated FDA OK for IgAN Proteinuria; Biogen’s BIIB080 Earns Fast Track for Alzheimer’s; Epicrispr’s EPI-321 Cleared by FDA for FSHD

medtech-news-for-abbott-zimmer-biomet-teleflex

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.

pharma-news-for-beam-astrazeneca-sanofi

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

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