fda clearance - Robuta Search

https://www.prnewswire.com/news-releases/acepodia-announces-fda-clearance-of-investigational-new-drug-application-for-ace2016-a-first-in-class-allogeneic-anti-egfr-cell-therapy-302052466.html Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE2016, a... Feb 4, 2024 - /PRNewswire/ -- Acepodia (6976:TT), a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation... new drug application fda clearance https://www.prnewswire.com/news-releases/acepodia-announces-fda-clearance-of-investigational-new-drug-application-for-ace1831-in-igg4-related-disease-302306506.html Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE1831 in... Nov 15, 2024 - /PRNewswire/ -- Acepodia (6976:TT), a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation... new drug application fda clearance https://www.marsbioimaging.com/article/mars-bioimaging-fda-clearance-photon-counting-ct MARS Bioimaging Receives FDA Clearance for Portable Photon-Counting CT Scanner MARS Bioimaging has received FDA 510(k) clearance for its portable photon-counting CT scanner, bringing premium musculoskeletal imaging to community and... photon counting ct fda clearance mars bioimaging receives https://www.asianhhm.com/news/zeta-surgical-gains-fda-clearance-to-expand ZETA SURGICAL gains FDA clearance to expand neurosurgical applications ZETA SURGICAL has received 510(k) clearance from the U.S. Food and Drug Administration for its Zeta Navigation System and associated instruments, including the... fda clearance zeta surgical gains expand https://news.gsmedtech.com/appliedvr-raises-36m-pursues-fda-clearance-of-first-digital-therapeutic/ AppliedVR raises $36M, pursues FDA clearance of first digital therapeutic Nov 12, 2021 - Medical Device News by Guided Solutions | The company is developing a digital therapeutic using VR to manage chronic lower back pain. It recently submitted an... fda clearance appliedvr raises first digital https://www.medicaldevice-network.com/marketdata/newsmedicis-technologies-liposonix-system-wins-fda-nod/ Medicis Technologies LipoSonix system gets FDA clearance - Medical Device Network Oct 27, 2011 - Medicis Pharmaceutical's subsidiary Medicis Technologies has received US Food and Drug Administration (FDA) clearance for its second generation LipoSonix... fda clearance medical device technologies liposonix system https://www.gleamer.ai/press/gleamer-receives-fda-clearance-for-chestview Gleamer Receives FDA Clearance for ChestView - Gleamer Medical-Grade AI for Radiology fda clearance receives chestview https://www.chemdiv.com/company/media/pharma-news/2017/akashi-therapeutics-receives-fda-clearance-resume-ht-100-clinical-development/ Akashi Therapeutics Receives FDA Clearance to Resume HT-100 Clinical Development -... Akashi Therapeutics Receives FDA Clearance to Resume HT-100 Clinical Development fda clearance akashi therapeutics receives https://golifeward.com/blog/rewalk-exoskeleton-receives-fda-clearance-for-stairs-and-curbs/ ReWalk Exoskeleton Receives FDA Clearance for Stairs and Curbs - Lifeward Oct 20, 2023 - Advancement in ReWalk Technology Achieves FDA Clearance as Only Personal Exoskeleton to Enable Use on Stairs and Curbs Paralyzed individuals with spinal cord... fda clearance rewalk exoskeleton receives stairs https://www.medtechdive.com/news/Medtronic-FDA-clearance-Stealth-AXiS-robotic-spine-system/812454/ Medtronic nets FDA clearance for robotic spine system | MedTech Dive Called Stealth AXiS, the surgical system builds on Medtronic’s Mazor robotic platform, as the medical device maker takes market share in the $15 billion... fda clearance medtronic nets robotic spine https://www.businesswire.com/news/home/20220721005025/en/RapidAI-Receives-FDA-Clearance-for-Rapid-Hyperdensity RapidAI Receives FDA Clearance for Rapid Hyperdensity RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clea... fda clearance receives rapid https://www.adra.ai/post/adravision-receives-food-and-drug-administration-clearance-for-its-adravision-perio-device Adravision Receives FDA Clearance for its Adravision Perio Device fda clearance receives perio device https://www.infectioncontroltoday.com/view/medlines-sterilization-wrap-receives-fda-clearance-compatability-3-sterilization Medline's Sterilization Wrap Receives FDA Clearance for Compatability With 3 Sterilization... May 12, 2026 - Infection Control Today serves infection control, facility, and C-suite leaders with strategies on HAIs, patient care, safety, and quality outcomes fda clearance medline sterilization wrap receives https://siliconbayounews.com/2015/01/27/bioceptive-receives-fda-clearance-for-first-medical-device/ Bioceptive Receives FDA Clearance for First Medical Device Jan 27, 2015 - Bioceptive Receives FDA Clearance for First Medical Device fda clearance receives first medical device https://www.cidrap.umn.edu/antimicrobial-stewardship/biomerieux-receives-fda-clearance-rapid-respiratorysore-throat-test BioMerieux receives FDA clearance for rapid respiratory/sore throat test | CIDRAP Company officials say the rapid PCR test could aid antimicrobial stewardship efforts. fda clearance sore throat receives https://www.gsmedtech.com/GS/NewsDetails/Armis-Biopharma-announces-FDA-clearance-for-VeriFixx-small-bone-implant Armis Biopharma announces FDA clearance for VeriFixx small bone implant VeriFixx is designed to make surgical corrections of this kind more accessible to patients through shorter time to ambulation, shorter overall recovery time... fda clearance armis biopharma announces small https://thevedsmovement.org/2021/12/15/aytu-biopharma-announces-fda-clearance-of-investigational-new-drug-ind-application-for-ar101-enzastaurin-in-vascular-ehlers-danlos-syndrome/ Aytu BioPharma Announces FDA Clearance of Investigational New Drug (IND) Application for... Dec 15, 2021 - Pivotal clinical trial will begin in first half of 2022 Aytu BioPharma, Inc. (Nasdaq: AYTU), a pharmaceutical company focused on commercializing novel... fda clearance https://www.globenewswire.com/news-release/2025/10/14/3166144/0/en/Tr1X-Announces-FDA-Clearance-of-IND-Application-for-TRX319-a-First-in-Class-Allogeneic-CAR-Tr1-Treg-Cell-Therapy-for-Progressive-Multiple-Sclerosis-and-50-Million-in-Additional-Fin.html Tr1X Announces FDA Clearance of IND Application for TRX319, Oct 14, 2025 - Tr1X announced the FDA has cleared its IND application for TRX319 in progressive multiple sclerosis and a $50M financing that extends its runway into... fda clearance announces ind application https://www.regdesk.co/blog/510k-submission-guide-how-to-prepare-and-submit-for-fda-clearance/ 510(k) Submission Guide: FDA Clearance Explained Apr 21, 2026 - Learn how to prepare and submit a 510(k) for FDA clearance, including requirements, timelines, and best practices. submission guide fda clearance k explained https://business-news-today.com/transcenta-gets-us-fda-clearance-for-launching-phase-1-trial-of-tst005/ Transcenta gets US FDA clearance for launching phase 1 trial of TST005 Apr 20, 2021 - Transcenta has secured clearance of its investigational new drug (IND) application for TST005 from the US Food and Drug Administration (FDA) for launching a... us fda https://www.qure.ai/us/news-press-coverages/qure.ai-continues-its-pace%20of-us-growth-with-19th-fda-clearance Qure.ai Earns 19th FDA Clearance for Neurocritical AI in U.S Qure.ai secures 19th FDA clearance in the U.S. for qER-CTA, an AI tool aiding stroke triage and expanding its portfolio in emergency and cancer care pathways. fda clearance qure ai earns https://simbiosys.com/2024/01/19/simbiosys-receives-milestone-fda-clearance-for-its-foundational-digital-precision-medicine-technology-tumorsight-enabling-expansion-to-future-cutting-edge-applications/ SimBioSys receives milestone FDA clearance for its foundational digital precision medicine... fda clearance digital precision receives milestone https://medtechspectrum.com/news/6/346/alveofit-receives-us-fda-clearance-for-alveoair-spirometer.html Alveofit receives US FDA clearance for alveoair spirometer Alveofit receives US FDA clearance for alveoair spirometer us fda receives clearance spirometer https://www.hospimedica.com/surgical-techniques/articles/294810080/augmented-reality-system-for-knee-replacement-receives-fda-clearance.html Augmented Reality System for Knee Replacement Receives FDA Clearance - Surgical Techniques -... May 5, 2026 - Augmented Reality System for Knee Replacement Receives FDA Clearance augmented reality system knee replacement fda clearance https://www.medtechdive.com/news/reprocessor-receives-fda-clearance-for-4-catheters/543000/ Reprocessor receives FDA clearance for 4 catheters | MedTech Dive fda clearance receives catheters medtech dive https://www.lighttreeventures.com/ja/post/understanding-fda-clearance-for-light-therapy-devices Understanding FDA Clearance for Light Therapy Devices Learn the FDA clearance process for light therapy devices, from 510(k) clearance to market access. Discover how FDA regulations affect compliance. fda clearance light therapy understanding devices https://pharmadevicenews.com/medtronic-secures-fda-clearance-for-stealth-axis-surgical-system-in-spine-robotics/ Medtronic secures FDA clearance for Stealth AXiS surgical system in spine robotics -... Feb 13, 2026 - Medtronic wins FDA clearance for Stealth AXiS in spine robotics. Explore what this integrated platform means for workflow, data, and adoption. fda clearance for stealth https://startllc.com/momentis-surgical-wins-fda-clearance-for-its-surgical-robot/ Momentis Surgical wins FDA clearance for its surgical robot - Start Medical Product Development Aug 18, 2025 - Momentis Surgical (formerly Memic) announced today that it received FDA 510(k) clearance for its Anovo robotic surgical platform. fda clearance https://avicenna.ai/resources/news/avicenna-ai-secures-fda-clearance-for-ai-detection-of-vertebral-compression-fractures/ Avicenna.AI Gains FDA Clearance For Fracture Detection Apr 27, 2026 - Avicenna.AI achieves FDA clearance for AI detection of vertebral compression fractures, improving incidental findings in medical imaging. fda clearance avicenna ai fracture detection https://www.ig.com/en-ch/news-and-trade-ideas/stock-of-the-day-nanosonics-250320 Can Nanosonics leverage FDA clearance for market growth? | IG Bank Switzerland Discover how Nanosonics' FDA De Novo clearance for the Coris system strengthens its market position. fda clearance market growth leverage https://www.medtechdive.com/news/intuitive-new-da-vinci-robot-fda-clearance/710436/ Intuitive lands FDA clearance for new da Vinci robot | MedTech Dive The soft tissue robotics leader incorporated new features into the system, from tissue sensing feedback to a smaller size and more comfortable console. da vinci robot fda clearance intuitive lands https://bluegoatcyber.com/ Medical Device Cybersecurity for FDA Clearance MedTech-only cybersecurity firm. Pen testing, SBOMs, threat modeling, and SPDF documentation that lands 510(k), De Novo, and PMA submissions on the first pass. medical device cybersecurity fda clearance https://www.nextfin.ai/en/custom/abbott-laboratories-stock-drops-fda-clearance-cef5ec8252 Abbott Laboratories Stock Drops 0.59% Despite Positive FDA Clearance News | NextFin Abbott Laboratories' stock closed at $90.79 on April 30, 2026, reflecting a decrease of $0.54 or approximately 0.59% from the opening price of $91.48. The... abbott laboratories https://www.ezra.com/en-gb/press-releases/ezra-receives-510-k-fda-clearance-for-ai-that-enhances-mri-enabling-fast-low-cost-scans Ezra Receives 510(k) FDA Clearance For AI That Enhances MRI, Enabling Fast, Low-Cost Scans Ezra Receives 510(k) FDA Clearance For AI That Enhances MRI, Enabling Fast, Low-Cost Scans https://www.pappas-capital.com/aktis-oncology-announces-fda-clearance-of-investigational-new-drug-applications-for-aky-2519/ Aktis Oncology Announces FDA Clearance of Investigational New Drug Applications for AKY-2519 -... Apr 15, 2026 - Aktis Oncology announces its FDA clearance of new investigation new drug. https://www.biospace.com/spinogenix-announces-fda-clearance-of-ind-application-for-spg302-a-novel-therapy-for-the-treatment-of-als Spinogenix Announces FDA Clearance of IND Application for SPG302, a Novel Therapy for the Treatment... Jul 17, 2024 - Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients... https://biopharmaboardroom.com/news/72/3847/sitryx-therapeutics-receives-fda-clearance-to-advance-syx-5219-into-phase-1b-trial-for-atopic-dermatitis.html Sitryx Therapeutics Receives FDA Clearance to Advance SYX-5219 Into Phase 1b Trial for Atopic... Sitryx Therapeutics Receives FDA Clearance to Advance SYX-5219 Into Phase 1b Trial for Atopic Dermatitis https://orthospinenews.com/2019/08/20/cutting-edge-spine-announces-fda-510k-clearance-of-its-evol-si-joint-fusion-system-bringing-novel-super-hydrophilic-nano-technology-to-the-sacral-iliac-fixation-market/ Cutting Edge Spine Announces FDA 510(K) Clearance of its EVOL-SI Joint Fusion System; Bringing... https://www.prnewswire.com/news-releases/tr1x-announces-fda-clearance-of-first-investigational-new-drug-application-for-trx103-an-allogeneic-regulatory-t-cell-therapy-to-treat-autoimmune-diseases-302112587.html Tr1X Announces FDA Clearance of First Investigational New Drug Application for TRX103, an... Apr 10, 2024 - /PRNewswire/ -- Tr1X, Inc., an autoimmune and inflammatory disease cell therapy company focused on the development of novel allogeneic regulatory T cell... new drug application https://flcube.com/?p=15031 Nasal-Phyto Pharmaceutical Receives FDA Clearance for First-Ever Olfactory Drug-Device Combo -... Nov 26, 2024 - China-based Nasal-Phyto Pharmaceutical Technology Group Co., Ltd has announced receiving clinical clearance from the US Food and Drug Administration (FDA) for... https://www.medtechdive.com/news/akura-medical-35m-510k-thrombectomy/695609/ Akura Medical secures $35M to pursue FDA clearance for thrombectomy device | MedTech Dive The money also will help fund clinical trials for additional indications and the expansion of its manufacturing capabilities. https://salesandmarketingnetwork.com/news_release_bs.html?pipe=0000ac177000191&ID=2036348&key=Smart+Catheter News for Medical Sales Reps: Sanovas Files for FDA Clearance of Vas Zeppelin(TM) Smart Catheter(TM) https://nordiclifescience.org/fda-expands-dignicap-clearance-us/ FDA expands Dignicap clearance in the US - NLS Jul 4, 2017 - Dignitana has received clearance from the U.S. Food and Drug Administration (FDA) to expand use of its medical device to patients in the United States... in the us fda expands dignicap clearance https://www.eisa.net.au/miracell-receives-fda-510k-clearance-for-smart-m-cell-prp-concentration-system-and-smart-m-cell-bone-marrow-concentration-system/ Miracell Receives FDA 510(k) Clearance for SMART M-CELL PRP Concentration System and SMART M-CELL... Apr 10, 2026 - Blood- and bone marrow-based efficient growth factors extraction system demonstrates substantial equivalence and high cell viability SEOUL, South Korea, April... https://www.hospimedica.com/glasses-free-3d-imaging-software-receives-fda-clearance-for-surgical-planning/articles/294810144/glasses-free-3d-imaging-software-receives-fda-clearance-for-surgical-planning.html Glasses-Free 3D Imaging Software Receives FDA Clearance for Surgical Planning - Surgical Techniques... May 6, 2026 - Glasses-Free 3D Imaging Software Receives FDA Clearance for Surgical Planning imaging software https://www.medlatest.com/specialty/healthcare/iom-to-fda-ditch-the-510k-clearance-program-for-medical-devices/ IOM to FDA: Ditch the 510(k) clearance program for medical devices - Medlatest - Medical Device News Aug 30, 2011 - The Institute of Medicine's much-anticipated independent review of the FDA's 510(k) clearance program for medical devices recommends that the entire program be... https://www.risetherapeutics.com/news/70-rise-therapeutics-receives-fda-ind-clearance-to-initiate-clinical-testing-of-r-5780-in-cancer Rise Therapeutics Receives FDA IND Clearance to Initiate Clinical Testing of R-5780 in Cancer At Rise Therapeutics, we develop targeted immunological-based biologics using a unique and proprietary oral delivery platform. We design and produce unique, fir https://www.prnewswire.com/news-releases/acepodia-announces-fda-clearance-of-ind-application-for-ace1831-an-anti-cd20-armed-allogeneic-gamma-delta-t-cell-therapy-candidate-to-treat-patients-with-non-hodgkins-lymphoma-301570711.html Acepodia Announces FDA Clearance of IND Application for ACE1831, an Anti-CD20 Armed Allogeneic... Jun 20, 2022 - /PRNewswire/ -- Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC)... https://www.digitalhealthglobal.com/earlitec-diagnostics-receives-fda-510k-clearance-for-the-earlipoint-evaluation-for-autism-spectrum-disorder-2/ EarliTec Diagnostics Receives FDA 510(k) Clearance for the EarliPoint Evaluation for Autism... Aug 23, 2022 - First FDA-cleared tool to assist clinicians in diagnosing and assessing autism spectrum disorder (ASD) in children as young as 16 months old ATLANTA--(BUSINESS... https://www.medtechdive.com/news/apple-watch-APPL-h2o-parkinsons-monitoring-FDA/637014/ Apple Watch app for monitoring Parkinson’s symptoms earns FDA clearance | MedTech Dive The technology has been validated in a clinical trial, positioning h2o to create an app that enables real-time sharing of Parkinson’s symptom data. apple watch app https://biohealthinnovation.org/qiagen-receives-fda-clearance-for-qiastat-dx-mini-panel-to-improve-precision-in-outpatient-respiratory-treatment/ QIAGEN receives FDA clearance for QIAstat-Dx mini panel to improve precision in outpatient... Jul 15, 2025 - Germantown, Maryland, and Venlo, the Netherlands, Oct. 29, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the... https://healthnewsofalabama.com/article/911074243-nrx-pharmaceuticals-nasdaq-nrxp-announces-fda-clearance-to-proceed-with-clinical-trial-of-nrx-101-in-combination-with-robotic-enabled-transcranial NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Clearance to Proceed with Clinical Trial of NRX-101... https://www.ophthalmologymanagement.com/news/2025/luminopia-announces-fda-clearance-for-patients-with-amblyopia-aged-8-to-12-years/ Luminopia Announces FDA Clearance for Patients with Amblyopia Aged 8 to 12 Years | Ophthalmology... Apr 22, 2025 - Conexiant Vision: Delivering trusted clinical content, deep audience engagement, and educational resources for eye care professionals. Discover more through... https://www.digitalhealthglobal.com/ge-healthcare-expands-on-device-triage-capabilities-of-critical-care-suite-with-fda-clearance-of-algorithm-for-pneumothorax-detection-notification-triage-and-diagnosis/ GE HealthCare Expands On-Device Triage Capabilities of Critical Care Suite with FDA Clearance of... Nov 29, 2023 - GE HealthCare announced an industry-first US FDA 510K clearance of Critical Care Suite 2.1 featuring a Pneumothorax (PTX) algorithm for the detection,... https://salesandmarketingnetwork.com/news_release_bs.html?pipe=0000ac177000191&ID=2037054&key=Isolaz News for Medical Sales Reps: Fraxel(R) Dual Laser System Receives New FDA 510(k) Clearance For... https://www.trivano.com/persbericht/philips-receives-fda-510k-clearance-for-its-rembra-platform-expanding-access-to-faster-more-precise-ct-imaging-across-frontline-care-and-cancer-treatment-planning-722630.html Philips receives FDA 510(k) clearance for its Rembra platform, expanding access to faster, more... April 22, 2026 Clearances for Rembra CT, Rembra RT, and Areta RT enable high-throughput imaging at scale and elevate precision across the cancer care pathway... https://losangeles.newsnetmedia.com/story/188104/clearpoint-neuro-announces-fda-clearance-of-the-velocity-alphar-mr-high-speed-surgical-drill-system-and-first-clinical-use-further-expanding-our-drug-delivery-ecosystem-and-global-footprint/ ClearPoint Neuro Announces FDA Clearance of the Velocity Alpha(R) MR High Speed Surgical Drill... https://betakit.com/fluidai-lands-fda-clearance-to-sell-post-surgery-monitor-in-the-us/ FluidAI lands FDA clearance to sell post-surgery monitor in the US | BetaKit Sep 25, 2025 - The Kitchener-Waterloo healthtech startup is eying Series B funding to fuel its US commercialization. https://www.djiboutihealthjournal.com/article/911074243-nrx-pharmaceuticals-nasdaq-nrxp-announces-fda-clearance-to-proceed-with-clinical-trial-of-nrx-101-in-combination-with-robotic-enabled-transcranial NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Clearance to Proceed with Clinical Trial of NRX-101... https://www.pharmafocusasia.com/news/artera-receives-us-fda-clearance-for-arteraai-breast Artera Receives U.S. FDA Clearance for ArteraAI Breast, Expanding Its AI Platform to Breast Cancer Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, today announced U.S. Food and Drug... https://orthospinenews.com/2024/08/20/si-bone-inc-receives-510k-clearance-and-fda-breakthrough-device-designation-for-pelvic-fracture-fixation-system/ SI-BONE, Inc. Receives 510(k) Clearance and FDA Breakthrough Device Designation for Pelvic Fracture... https://lifestyle.capitalcityrock.com/story/67607/cstone-announces-fda-clearance-of-ind-application-for-its-novel-trispecific-antibody-cs2009-pd-1-vegf-ctla-4-to-advance-into-phase-ii-clinical-trial/ CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009... https://news.lifesciencenewswire.com/newsroom/indica-labs-receives-fda-clearance-for-halo-ap-dx-digital-pathology-platform-for-use-with-hamamatsu-images-acquired-with-the-nanozoomer-s360md-slide-scanner Indica Labs receives FDA clearance for HALO AP Dx digital pathology platform for use with Hamamatsu... Indica Labs and Hamamatsu Photonics K.K. has announced that the U.S. FDA has issued a 510(k) clearance to Indica Labs for HALO AP Dx, an enterprise digital... https://www.gehealthcare.com/en-us/about/newsroom/press-releases/ge-healthcares-photonova-spectra-photon-counting-ct-receives-fda-clearance GE HealthCare’s Photonova Spectra photon-counting CT receives FDA clearance | GE HealthCare (United... FDA clearance quickly follows Photonova Spectra’s debut at the Radiological Society of North America (RSNA) 2025 Annual Meeting, marking rapid momentum for GE... photon counting ct https://www.businesswire.com/news/home/20250512968719/en/Lantern-Pharma-Secures-FDA-Clearance-for-Planned-Phase-1b2-Trial-of-LP-184-in-Biomarker-Defined-Treatment-Resistant-NSCLC-Patients-with-High-Unmet-Clinical-Need Lantern Pharma Secures FDA Clearance for Planned Phase 1b/2 Trial of LP-184 in Biomarker-Defined,... Lantern Pharma Inc. (Nasdaq: LTRN), an artificial intelligence company developing targeted and transformative cancer therapies using its proprietary AI platf... https://femtechinsider.com/mosie-baby-fda-class-ii/ Mosie Baby Achieves FDA Class II Clearance for At-Home Intravaginal Insemination Kit | Femtech... Dec 6, 2023 - Mosie Baby, an at-home fertility care company, has recently obtained FDA Class II clearance for its Mosie Baby Kit. This clearance positions the Mosie Baby Kit... https://www.medwrench.com/article/29937/viewray-receives-fda-510-k-clearance-for-mri-guided-radiation-therapy-system ViewRay Receives FDA 510(k) Clearance for MRI-Guided Radiation Therapy System | MedWrench MedWrench article ViewRay Receives FDA 510(k) Clearance for MRI-Guided Radiation Therapy System https://via.tt.se/pressmeddelande/4356514/vensica-medical-receives-fda-ind-clearance-to-initiate-phase-2-study-of-vixe-its-needle-free-xeomin-r-delivery-system-for-overactive-bladder?publisherId=259167&lang=en Vensica Medical Receives FDA IND Clearance to Initiate Phase 2 Study of ViXe, Its Needle-Free... Vensica Medical, a clinical-stage company developing needle-free therapeutic delivery solutions for urologic diseases, today announced that the U.S. Food and... https://diagnostics.roche.com/me/en/news-listing/2025/roche-receives-fda-clearance-for-new-highly-sensitive-test-to-aid-clinicians-in-diagnosing-b-cell-lymphoma.html Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell... The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to... https://www.oleantimesherald.com/2024/11/04/huidagene-therapeutics-receives-the-first-ever-fda-clearance-of-crispr-cas13-rna-editing-hg202-for-macular-degeneration/ HuidaGene Therapeutics Receives the First-Ever FDA Clearance of CRISPR/Cas13 RNA-Editing HG202 for... Nov 19, 2024 - HG202 is the first CRISPR/Cas13Y RNA-targeting therapy to enter clinical development and the only clinical-stage CRISPR RNA-editing therapy for age-related... https://medicaex.com/businesswire/from-global-success-to-us-breakthrough-twoplus-applicator-celebrates-fda-clearance-after-helping-thousands-in-the-uk-and-asia-2/ From Global Success to US Breakthrough: twoplus Applicator Celebrates FDA Clearance After Helping... WILMINGTON, Del.--(BUSINESS WIRE)--twoplusTM, a YCombinator-backed startup, announces US Food and Drug Administration (FDA) clearance for the twoplusTM https://hlth.com/insights/news/a-first-as-graymatters-health-receives-fda-clearance-for-ptsd-neuromodulation-therapy-2023-03-28 A first, as GrayMatters Health receives FDA clearance for PTSD neuromodulation therapy https://www.biospace.com/anixa-biosciences-and-cleveland-clinic-announce-fda-clearance-to-initiate-clinical-trial-of-breast-cancer-vaccine Anixa Biosciences and Cleveland Clinic Announce FDA Clearance to Initiate Clinical Trial of Breast... Dec 21, 2020 - Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced today that... https://www.pharmatomarket.com/thailand-fda-implements-gmp-clearance-temporary-process-during-covid-19-pandemic/ Thailand FDA Implements GMP Clearance Temporary Process During COVID-19 Pandemic - Pharma To... Oct 18, 2022 - The State Drug Regulatory Authorities overseas, responsible for the assessment of manufacturing standards according to GMP principle, have postponed the ...