Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Intuitive’s da Vinci 5 Gets CE Mark; Boston Scientific’s FARAPULSE™ Secures Expanded FDA Approval; Trividia Health’s TRUE METRIX® Added to Pennsylvania Medicaid List; Cerapedics’ PearlMatrix™ Sees First U.S. Clinical Use Post-FDA Nod; Smith+Nephew Expands Q-FIX◊ with Knotless Option; Cochlear Unveils World’s First Smart Cochlear Implant

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Merck’s WINREVAIR Granted FDA Priority Review for Pulmonary Arterial Hypertension; KalVista’s EKTERLY Approved by FDA as First Oral On-Demand Therapy for Hereditary Angioedema; Fujifilm’s FF-10832 Receives FDA Orphan Drug Designation for Biliary Tract Cancer; Mustang Bio’s MB-101 Granted FDA Orphan Drug Designation for Glioblastoma and Astrocytomas; Denali’s Tividenofusp Alfa Accepted for FDA Priority Review for Hunter Syndrome

medtech-news-for-stryker-glaukos-stentit

FDA Clears Stryker’s Incompass Total Ankle System; Glaukos Receives EU MDR Approval for iStent infinite and Key MIGS Devices; STENTiT Announces First Patient Enrollment in Trial of Regenerative Stent for Limb Preservation; Autonomix Medical Treats First Patient in Next Phase (“PoC 2”) of Proof-of-Concept Clinical Trial; Getinge Expands Servo-C Ventilator Capabilities for Neonatal Care; Medtronic Partners With Philips to Advance Patient Monitoring Solutions

pharma-news-for-sobi-gsk-ultragenyx

Sobi’s GAMIFANT Approved by FDA as First Treatment for Macrophage Activation Syndrome in Still’s Disease; GSK Cuts RTS,S Malaria Vaccine Price for Children in Endemic Regions to Under $5; Schrödinger’s SGR-1505 Receives FDA Fast Track Designation for Relapsed/Refractory Waldenström Macroglobulinemia; Ultragenyx’s GTX-102 Granted FDA Breakthrough Therapy Designation for Angelman Syndrome; Eli Lilly’s AMYVID Label Updated by FDA to Support Alzheimer’s Disease Diagnosis

medtech-news-for-ge-healthcare-inspiremd-angiodynamics

GE HealthCare Receives FDA Approval for Expanded Vizamyl PET Imaging Indications in Alzheimer’s Disease Care; FDA Grants Approval to InspireMD’s CGuard® Prime for Carotid Artery Disease; AngioDynamics Launches RECOVER-AV Trial, Marking Milestone in AlphaVac F18⁸⁵ Development for PE Treatment; Tivic Health Concludes Study Optimizing Non-Invasive Vagus Nerve Stimulation Device for Personalized Therapy; Johnson & Johnson Introduces VOLT™ Plating System and ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM in the U.S.

pharma-news-for-incyte-gilead-archeus

Incyte’s MONJUVI Combo Approved by FDA for Relapsed/Refractory Follicular Lymphoma; Gilead’s YEZTUGO Becomes First FDA-Approved HIV Prevention with 6-Month Protection; FDA Reviewing Incyte’s OPZELURA for Pediatric Atopic Dermatitis (Ages 2–11); Archeus Technologies Receives FDA Clearance for Prostate Cancer Therapy ART-101; Cycle Pharmaceuticals’ HARLIKU Gets First FDA Approval for Alkaptonuria

medtech-news-for-presidio-medical-creo-medical-penumbra

Presidio Medical™ Gains IDE Nod for ULF™ Study, Names Dimas Jiménez CFO; Creo Medical Gains FDA Nod for SpydrBlade™ Flex, Paving Way for U.S. Launch; Penumbra Completes Patient Enrollment in Pivotal STORM-PE RCT; Adona Medical Completes Enrollment in First-in-Human Trial of Novel Interatrial Shunt for Heart Failure; Johnson & Johnson Launches TECNIS Odyssey Intraocular Lens in Europe, Middle East, and Canada for Enhanced Cataract Care; Philips Sets New Benchmark in POCUS Technology with Flash 5100 Launch

pharma-news-for-celltrion-csl-ocugen

Celltrion Announces FDA Nod for New STEQEYMA Presentation to Broaden Pediatric Use; CSL’s ANDEMBRY Gets FDA Nod as First Factor XIIa Inhibitor for Hereditary Angioedema; Ocugen’s OCU410ST Cleared by FDA to Begin Phase II/III Trial in Stargardt Disease; Milestone Pharmaceuticals Submits FDA Response for CARDAMYST in PSVT; AbbVie’s MAVYRET Approved by FDA as First and Only Therapy for Acute Hepatitis C

medtech-news-for-samsung-masimo-penumbra

Samsung Galaxy Watch Sleep Apnea Feature Cleared for Europe With CE Certification; ZEISS CLARUS 700 Gains NMPA Approval in China; Envoy Medical’s Acclaim® Cochlear Implant Trial Progresses as Planned Following First Month Follow-Up; Masimo SedLine® Shown to Enhance Brain Monitoring Accuracy in Pediatric Anesthesia; Penumbra Launches Ruby® XL System; Johnson & Johnson Introduces the ETHICON™ 4000 Stapler

pharma-news-for-amylyx-cellectar-merck

Amylyx’s AMX0114 Fast Tracked by FDA for ALS; Cellectar’s Iopofosine I 131 Granted FDA Breakthrough in Waldenstrom Macroglobulinemia; YolTech’s YOLT-101 Clears FDA IND for Familial Hypercholesterolemia; Oncovita’s MVdeltaC Gets FDA Orphan Tag for Pleural Mesothelioma; Merck’s ENFLONSIA Approved for RSV Prevention in Infants

medtech-news-for-guardant-health-reflow-medical-bd

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

pharma-news-for-beam-incannex-kura

Beam’s BEAM-302 Earns FDA Orphan Drug Tag for AATD; Incannex’s IHL-42X Moves to Phase III After FDA Protocol OK; Kura and Kyowa Kirin’s Ziftomenib Gets FDA Priority Review in NPM1-Mutant AML; GSK’s Linerixibat NDA Accepted by FDA for PBC-Linked Pruritus; Ascendis’ TransCon CNP Granted FDA Priority Review for Achondroplasia

medtech-news-for-olympus-abbott-sensome

Olympus Gains FDA Clearance for EDOF™ Imaging Endoscopes; FDA Approves Abbott’s Tendyne™ Device for Minimally Invasive Mitral Valve Replacement; New Study Validates Exact Sciences’ Oncodetect™ for Enhanced MRD Detection in Stage II-IV Colorectal Cancer; Sensome Completes First-in-Human Trial Enrollment for Lung Cancer Detection System; J&J MedTech Introduces SOUNDSTAR CRYSTAL™ to US Market with Breakthrough 2D Imaging Quality; Terumo Launches ROADSAVER™ Carotid Stent System to Improve Outcomes in Carotid Artery Stenosis

pharma-news-for-gilead -otsuka-liquidia

Gilead’s TRODELVY Shows PFS Benefit in 1L Metastatic TNBC; Otsuka’s Sibeprenlimab Gets FDA Priority Review for IgA Nephropathy; Liquidia Wins FDA Nod for YUTREPIA in PAH and PH-ILD; GSK’s BLENREP Combos Get CHMP Backing in Myeloma; Relief Therapeutics Receives FDA Rare Pediatric Disease Tag for RLF-TD011

medtech-news-for-fujirebio-stryker-abbott

FDA Clears Fujirebio’s Lumipulse® G Plasma Test for Detecting Alzheimer’s-Linked Amyloid Pathology; Stryker Gains FDA Clearance for OptaBlate® BVN System to Treat Chronic Low Back Pain; Abbott Unveils Clinical Evidence Linking Libre® CGM to Reduced Cardiovascular Events in Diabetes; GE HealthCare Launches AI-Based CleaRecon DL for Enhanced 3D Reconstruction in Interventional Suites; Philips Advances Cardiac Care with Launch of RADIQAL Clinical Study and Real-Time 3D Intracardiac Imaging Catheter in Europe

pharma-news-for-incyte-abbvie-merck

Incyte’s ZYNYZ Approved as First-Line Treatment for Advanced Anal Cancer; Amneal Gets FDA Nod for BREKIYA for Migraines; FDA Accepts Travere’s sNDA for FILSPARI in FSGS; AbbVie’s EMRELIS Approved for Advanced NSCLC With High c-Met; Merck’s WELIREG Approved for Advanced PPGL in Patients 12+

medtech-news-for-glucotrack-ge-healthcare-bd

Glucotrack Secures Ethical Approval for Extended Clinical Trial of Continuous Blood Glucose Monitor; GE HealthCare Announces FDA Approval for Pediatric Use of Optison and Launches New Ultra-premium 1.5T MRI System; Envoy Medical Advances to Final Stage Following Clinical Milestone; SeaStar Medical Hits Interim Enrollment Goal in NEUTRALIZE-AKI Trial; BD Unveils New Cell Analyzer Integrating Spectral and Real-Time Imaging Innovations

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