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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Stereotaxis and Shanghai MicroPort EP Medtech Co., Ltd. Receives Approval for Magbot Robotic Magnetic Navigation Ablation Catheter From China’s NMPA; AngioDynamics NanoKnife® System Approved by FDA for Prostate Tissue Treatment; Zynex Successfully Completes Laser Pulse Oximetry Clinical Trial; COTA, PreciseDx, and Baptist Health Validate AI-Powered PreciseBreast as Equivalent to Oncotype DX; Medtronic Introduces Percept™ RC Rechargeable Neurostimulator; Crown Aesthetics Raises the Bar with the Introduction of SkinPen® Precision Elite

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pharma-news-for-abbvie-gsk-novartis

AbbVie Reveals Phase III TEMPO-2 Trial Positive Topline Results; FDA Accepts GSK’s NUCALA Submission in COPD; Novartis Boosts Huntington’s Disease Development Program with PTC518 In-Licensing; Chimerix to File for Accelerated FDA Approval of Dordaviprone for H3 K27M-Mutant Diffuse Glioma; MeiraGTx Receives FDA RMAT Designation for AAV2-hAQP1 in Grade 2/3 Radiation-Induced Xerostomia Treatment

medtech-news-for-zimmer-biomet-orthocell-hologic

FDA Approves Zimmer Biomet’s Oxford® Cementless Partial Knee; ReCerf® Sets Milestone as First All-Ceramic Hip Resurfacing Approved Worldwide; Orthocell Achieves US FDA 510(k) Clearance Milestone for Remplir Regulatory Study; Hologic’s Research Shows AI Breast Imaging Maintains Performance Across All Demographics; GE HealthCare Expands MRI Capabilities with Sonic DL’s Advanced Deep Learning; Terumo Unveils the R2P NaviCross Peripheral Support Catheter

pharma-news-for-applied-therapeutics-alnylam-rigel

FDA Grants Fast Track for Lin BioScience’s LBS-007; Alnylam’s AMVUTTRA sNDA Under Review; FDA Approves RAPIBLYK for Atrial Fibrillation; Applied Therapeutics Receives CRL for Govorestat in Galactosemia; R289 Gets Fast Track for Lower-Risk MDS.

medtech-news-for-medtronic-zimmer-biomet-abbott

FDA Clears Medtronic’s New Inpen™ App; Zimmer Biomet Gets FDA Approval for Oxford® Cementless Partial Knee; Perimeter B-Series OCT with ImgAssist AI 2.0 Shows Significant Superiority Over Standard-of-Care in Pivotal Clinical Trial; Edwards’ SAPIEN 3 Ultra RESILIA Valve Maintains Exceptional Patient Outcomes in Real-World Settings; Abbott Introduces AVEIR™ VR Leadless Pacemaker System to Indian Market; GE HealthCare’s Pristina Via Transforms Mammography with Improved Workflow and Patient Care

pharma-news-for-Ractigen-intellia -bridgebio

FDA Grants Orphan Drug Designation for Ractigen’s RAG-21 in ALS; Intellia’s Nexiguran RMAT for ATTR Amyloidosis; FDA Approves Acoramidis for ATTR-CM; Jazz Wins FDA Approval for Ziihera in HER2-Positive Biliary Cancer; J&J Seeks FDA Approval for Subcutaneous TREMFYA in Colitis

medtech-news-of-cartessa-logicmark-boston-scientific

Cartessa Aesthetics teams with Classys for Everesse; LogicMark unveils Freedom Alert Max; GE HealthCare clears SIGNA MAGNUS MRI; OMRON’s BP monitor with AI-powered AFib detection gets FDA approval; Boston Scientific’s WATCHMAN FLX™ cuts bleeding risk; Encora Therapeutics wraps ULTRE trial for tremor device

pharma-news-for-regeneron-astrazeneca-syndax

FDA Approves PTC’s AADC Gene Therapy; DUPIXENT sBLA Acceptance for Urticaria; CHMP Recommends TAGRISSO for EGFR Lung Cancer; FDA Approves DANZITEN for CML; Syndax Wins FDA Approval for REVUFORJ in Acute Leukemia

medtech-news-for-organogenesis-livanova-hyperfine

FDA Grants Approval to Caris Life Sciences for MI Cancer Seek; Johnson & Johnson MedTech Secures FDA IDE Approval for OTTAVA; Organogenesis Shares Positive Interim Data from Second Phase 3 Study of ReNu; LivaNova’s OSPREY Trial Achieves Key Safety and Efficacy Milestones; Hyperfine Launches Advanced Portable MR Brain Imaging Swoop® System Across Europe; Nihon Kohden Strengthens Neurological Solutions Through Ad-Tech Medical Instrument Corporation Acquisition

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

medtech-news-for-beta-bionics-philips-seemedx

Beta Bionics Introduces iLet Bionic Pancreas with Abbott’s FreeStyle Libre 3 Integration; Merit Medical Successfully Acquires Cook Medical’s Lead Management Portfolio; Elixir Medical’s LithiX HC-IVL System Maintains Safety and Efficacy at Six-Month Mark; Philips Launches U.S. Clinical Trial with First Patient Enrolled for New Integrated Device for PAD; FDA Grants iRhythm Technologies 510(k) Clearance for Enhanced Zio AT Device; SeeMedX Submits 510(k) for Cardiac Monitoring System Aiming to Revolutionize Heart Failure Management

Pharma-news-for-prolong-shorla-novartis

Prolong’s PP-007 Fast-Tracked for Stroke; FDA Expands JYLAMVO Pediatric Approval; Corcept’s Cushing’s Drug Shows Positive Phase III Results; ESSA Halts Phase II Study of Masofaniten for Prostate Cancer; SCEMBLIX Approved for Leukemia

medtech-news-for-medtronic-abbott-wellsky

Medtronic Secures FDA Green Light for Affera™ Mapping and Ablation System Alongside Sphere-9™ Catheter; Precision Optics Gets FDA 510(k) Clearance; Abbott Launches New Clinical Trial Aimed at Enhancing Care for Advanced Heart Failure Patients; Fresenius Medical Care’s Study Confirms Efficacy of New Anemia Therapy Software in Enhancing Outcomes for Hemodialysis Patients; Inspira™ Announces New Distribution Center to Support INSPIRA™ ART100’s U.S. Introduction; WellSky Expands Home Care Offerings with Acquisition of Bonafide

Pharma-news-for-modalis-pfizer-hibercell

FDA Grants Orphan Status to MDL-101 for LAMA2-CMD; Pfizer’s ABRYSVO Approved for High-Risk Adults (18-59); KIND’s AND017 Gains Orphan Designation for Sickle Cell Disease; HiberCell’s HC-7366 Fast-Tracked for AML; ORLYNVAH Approved for Uncomplicated UTIs

medtech-news-for-endospan-boston-scientific-ge-healthcare

iRhythm’s Zio® AT Device Improvements Receive FDA Clearance; Epitel Adds REMI AI Device to Portfolio with Fourth FDA 510(k); SeaStar Medical Advances Acute Kidney Injury Trial, Approaches Interim Analysis; Endospan Completes Primary Enrollment for TRIOMPHE Study of NEXUS® Stent Graft; Boston Scientific Enhances FARAPULSE™ PFA with New Cardiac Mapping Technology; GE HealthCare Debuts CareIntellect to Support Oncologists with AI-Enhanced Patient Insights

pharma-news-for-gilead-merck-astellas

Gilead and Merck Announce Encouraging Phase II Results of Islatravir and Lenacapavir Combo; REGENXBIO Highlights Positive Data from Phase II ABBV-RGX-314 Wet AMD Study at AAO 2024; FDA Greenlights Astellas’ VYLOY for Advanced Gastric and GEJ Cancer Therapy; Merck’s CAPVAXIVE Vaccine Yields Strong Immune Response in Adults Vulnerable to Pneumococcal Disease; FDA Postpones LUMAKRAS Colorectal Cancer Verdict to Early 2025

medtech-news-for-roche-bausch-lomb-abbott

Roche Receives FDA Approval for Itovebi; FDA Approves Bausch + Lomb’s Envista® Envy™; Microbot Medical Successfully Completes Pivotal Human Clinical Trial and Accelerates Go-to-Market Strategy for LIBERTY® Launch; Positive FDA Guidance on Phase III Trial of 64Cu-SAR-Bispsma for Recurrent Prostate Cancer; ELEHEAR Launches Hearing Aids at Just $399; Abbott Advances Pulsed Field Ablation Studies and Launches New Technology for Cardiac Mapping

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