Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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

pharma-news-for-astrazeneca-vertex-axsome

AstraZeneca Scraps £450M UK Vaccine Factory; FDA Approves First Non-Opioid Pain Reliever JOURNAVX in 20+ Years; Axsome’s SYMBRAVO Wins FDA Nod for Migraine; March Biosciences’ MB-105 Gains FDA Orphan Status for T-Cell Lymphoma; Saol’s SL1009 NDA Accepted for Pyruvate Dehydrogenase Complex Deficiency

medtech-news-for-norlase-lunit-lumicell

Norlase’s LYNX Receives FDA and CE Approval for Clinical Use; FDA Approves Imperative Care’s Zoom System; Lunit AI Enhances Predictive Accuracy for HER2-Targeted Therapy in Metastatic Colorectal Cancer; ImmunoMet Reports New Insights from Phase 1b Study of Lixumistat in Pancreatic Cancer; Lumicell Announces U.S. Launch of LumiSystem; Inventia Life Science Introduces RASTRUM™ Allegro to Advance High-Throughput 3D Cell Culture

pharma-news-for-eisai-vanda-cartesian

FDA Approves LEQEMBI IV Dosing for Early Alzheimer’s; Vanda Accepts FDA Hearing on Tradipitant for Gastroparesis; Cartesian Gains FDA Protocol Approval for Myasthenia Gravis Trial; Zai Lab Secures FDA Orphan Status for DLL3 ADC in SCLC; Dyne Receives FDA Fast Track for DYNE-101 in Myotonic Dystrophy

medtech-news-for-tempus-b-braun-telix

Tempus Launches FDA-Approved xT CDx Test Nationwide; B. Braun Enhances Catheter Securement with the Launch of Clik-FIX; Illuccix® Secures European Regulatory Approval; FDA Clears CapsoCam Plus® for Remote Ingestion; BellaSeno Marks Success in Two Clinical Trials for Revolutionary Breast Implant Technology; AF Symposium to Feature Conformal Medical’s Groundbreaking GLACE Study

pharma-news-for-amgen-novo-nordisk-boehringer

FDA Approves LUMAKRAS with VECTIBIX for KRAS G12C-Mutated Colorectal Cancer; PYC Receives FDA Rare Pediatric Disease Designation for VP-001; Novo Nordisk Links High-Dose WEGOVY to Increased Weight Loss; FDA Rejects Atara’s EBVALLO Due to Manufacturing Issues; Boehringer Faces Phase III Schizophrenia Fail and Legal Challenges

medtech-news-for-medtronic-inquis-medical-argon-medical

Johnson & Johnson MedTech Secures CE Mark for Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter; Medtronic Secures CE Mark for BrainSense™ Adaptive Deep Brain Stimulation; Inquis Medical Finalizes Enrollment for U.S. Pivotal Study on Aventus Thrombectomy System for Pulmonary Embolism; First Patient Enrolled in Argon Medical’s CLEAN-PE Study for Novel Pulmonary Embolism Therapy; Sutter Health and GE HealthCare Partner to Revolutionize Patient Care with AI-Driven Imaging Solution; Saluda Medical Closes $100M Financing to Expand Neuromodulation Portfolio

pharma-news-for-agios-bridgebio-rigel

Agios’ PYRUKYND SNDA Accepted by FDA for Thalassemia; BridgeBio’s BBO-8520 Gets FDA Fast Track for KRASG12C-Mutated Lung Cancer; Nipocalimab Granted FDA Priority Review for Myasthenia Gravis; Rigel’s R289 Receives FDA Orphan Drug Designation for MDS; Rise Therapeutics Gets FDA IND Clearance for R-5780 in Cancer

medtech-news-of-roche-nanovibronix-hologic

Roche Secures FDA Clearance for High-Volume Slide Scanner; Pacira Gets 510(k) Approval for Iovera° SmartTip for Chronic Back Pain; ClearCut Presents Clearcoast™ Study Results at San Antonio Breast Cancer Symposium; NanoVibronix Completes UroShield® Pilot Study at University of Michigan; Hologic Finalizes Acquisition of Gynesonics; Movano Health Launches EvieAI Virtual Wellness Assistant.

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