Notizia - Recent Pharma, Healthcare and Biotech Happenings

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

Notizia - Recent Pharma, Healthcare and Biotech Happenings

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

Explore More...
medtech-news-for-esaote-medmira-moleculight

Esaote’s MyLab™ A50 and A70 Ultrasound Systems Achieve FDA 510(k) Clearance; Health Canada Approves MedMira’s Reveal® TP Rapid Test for Syphilis; MolecuLight’s Transformative Effect on Wound Care Confirmed by Large Randomized Trial; Arctx Medical’s ACC Kit Receives FDA IDE Approval and Dr. Robert Kieval Appointed CEO; Quest’s Haystack MRD Test Awarded FDA Breakthrough Device Designation for Post-Surgical Colorectal Cancer Monitoring; Sonic Healthcare USA Strengthens Oncology Diagnostics with Acquisition of Cairo Diagnostics

pharma-news-for-madrigal-valneva-protagonist

Madrigal Wins EU Approval for REZDIFFRA in MASH With Liver Fibrosis; Valneva Faces FDA License Suspension for Chikungunya Vaccine IXCHIQ; Coya Secures FDA IND Clearance for COYA 302 in ALS Treatment; Rusfertide Earns FDA Breakthrough Therapy Designation for Polycythemia Vera; Crinetics Gains FDA Orphan Drug Status for Atumelnant in Congenital Adrenal Hyperplasia

medtech-news-for-nerveblox-labcorp-calidar

FDA Grants 510(k) Clearance to Nerveblox AI; Labcorp Introduces the First FDA-Cleared Alzheimer’s Blood Test; Calidar Introduces First-of-its-Kind 4D Mammography System; ONWARD Medical to Initiate Empower BP Pivotal Study Following FDA IDE Approval; Tenon® Medical Launches Catamaran® SE SI Joint Fusion System Nationwide; Rivanna Secures $800,000 Virginia Catalyst Grant Plus Matching Funds to Advance AI-Driven Ultrasound Innovation

pharma-news-for-precigen-regenxbio-tonix

Precigen’s PAPZIMEOS Wins Full FDA Approval for Recurrent Respiratory Papillomatosis; Tonix’s Tonmya Becomes First FDA-Approved Fibromyalgia Treatment in Over 15 Years; FDA Extends BLA Review for REGENXBIO’s RGX-121 in MPS II Patients; SystImmune’s Izalontamab Brengitecan (EGFRxHER3 ADC) Gets FDA Breakthrough Designation for EGFR-Mutated NSCLC; Soligenix Granted FDA Orphan Drug Status to SGX945 for Behçet’s Disease Therapy Following Phase II Success

medtech-news-for-nyxoah-deepsight-technology-myra-vision

Nyxoah Secures FDA Nod for Genio® System in OSA Treatment; FDA Grants First 510(k) Clearance to DeepSight™-Powered NeedleVue™ LC1 Ultrasound System; TITAN CSR® Retractor Tops U.S. Military List for Trauma Care in Deployed Settings; FDA Clears Myra Vision to Begin US IDE Study for Glaucoma; HistoIndex Advances Fibrosis Assessment with AI-Powered FibroSIGHT™ Plus; Gentuity Partners with GE HealthCare to Broaden Access to Cutting-Edge Intravascular Imaging

pharma-news-for-boehringer-genmab-tiziana

Teva’s AJOVY Expanded by FDA as First Anti-CGRP Preventive for Pediatric Episodic Migraine; NRx Pharma’s NRX-100 Granted FDA Fast Track for Suicidal Ideation in Depression/Bipolar Depression; Boehringer Ingelheim’s HERNEXEOS Wins FDA Accelerated Approval for HER2-Mutant Advanced NSCLC; Genmab’s Phase III EPCORE FL-1 Meets Dual Endpoints in Relapsed/Refractory Follicular Lymphoma; Tiziana’s Phase II IND Cleared by FDA for Multiple System Atrophy

medtech-news-for-setpoint-medical-body-vision-medical-demetra

SetPoint Medical Earns FDA Nod for First-of-Its-Kind Neuroimmune Modulation Therapy in RA; Body Vision Medical Secures Singapore Pre‑Market Approval for LungVision; BioLab Holdings Initiates Landmark Clinical Trial for Placental Membrane Therapies; Concept Medical Launches MAGICAL-SV IDE Trial; Frenova Enters Strategic Partnership to Push Boundaries in Kidney Precision Medicine; Demetra Acquires OrthoFundamentals and Establishes Global Spine Division

medtech-news-for-philips-roche-cortec

Philips Secures FDA Nod for Image-Guided Platform in Prostate Cancer Treatment; Roche Gains CE Mark for Alzheimer’s Screening Blood Test; CorTec Completes First Human Implantation of Its Brain-Computer Interface in Neurotech Breakthrough; Natera Initiates ABCSG 61 Trial to Assess Signatera™ in Early-Stage Breast Cancer; GE HealthCare Introduces Advanced Digital X-ray System to Enhance Imaging Accessibility in High-Volume Settings; Stryker-Owned Inari Medical Launches InThrill® System for AV-Access and Small Vessel Thrombus Treatment

pharma-news-for-ascendis-apellis-entera

Ascendis Pharma’s SKYTROFA Approved by FDA for Adult Growth Hormone Deficiency; Apellis Wins FDA Approval for EMPAVELI in C3G and IC-MPGN Treatment; FDA Approves PTC Therapeutics’ Sephience for Phenylketonuria; MAIA Biotechnology’s Ateganosine Gets FDA Fast Track for Non-Small Cell Lung Cancer; Entera Bio Gets FDA Nod on BMD as Primary Endpoint for Phase III Osteoporosis Study

Default Blog Image

Medtronic Gains CE Mark for MiniMed™ 780G, Begins Onyx™ IDE Study; FDA Clears RIVANNA’s AI Ultrasound Guidance Platform; BD Launches First Clinical Trial with Libertas™ Wearable Injector; Olympus Debuts EU-ME3 Ultrasound Processor in U.S.; Thermo Fisher & Sanofi Expand U.S. Drug Manufacturing Partnership

pharma-news-for-sarepta-imcheck-redhill

Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths; ImCheck’s ICT01 Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia; RedHill Biopharma Gets Positive FDA Feedback on RHB-204 for Crohn’s Disease Approval Pathway; FDA Grants Fast Track Designation to ProMIS Neurosciences’ PMN310 for Alzheimer’s Disease; Oruka Therapeutics Receives IND Clearance for Phase IIa Trial of ORKA-001 in Psoriasis

medtech-news-for-medtronic-microport-olympus

Medtronic Gains CE Mark for LigaSure™ on Hugo™ Robotic System; J&J Wins FDA Nod for VARIPULSE™ Irrigation Update; DSMB Clears Continuation of Aethlon Medical Clinical Study; MicroPort® CardioFlow Marks First VitaFlow Liberty® Implants in South Korea; Olympus Unveils EU-ME3 Ultrasound Processor in U.S.; QuidelOrtho, BÜHLMANN Launch fCAL® & fPELA® Turbo Assays on VITROS™

pharma-news-for-bayer-klotho-trethera

Nanoscope’s MCO-010 Begins FDA Rolling Submission for Retinitis Pigmentosa; Bayer’s KERENDIA Approved by FDA for Heart Failure With Preserved Ejection Fraction; Klotho Neurosciences’ KLTO-202 Receives FDA Orphan Drug Designation for ALS; Trethera’s TRE-515 Granted FDA Fast Track Designation for Metastatic Prostate Cancer; Adcentrx’s ADRX-0405 Awarded FDA Orphan Drug Designation for Gastric Cancer

medtech-news-for-intuitive-boston-scientific-cerapedics

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

pharma-news-for-merck-kalvista-mustang

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

Subscribe to our Updates

DelveInsight is dedicated to safeguarding your data. We ensure that your information is handled in compliance with relevant data privacy legislation, our internal guidelines, and our privacy policy.

Receive recent Healthcare updates directly in your inbox.

Days
loader