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https://www.biospace.com/setpoint-medical-receives-fda-breakthrough-device-designation-for-its-neuroimmune-modulation-platform-for-the-treatment-of-multiple-sclerosis SetPoint Medical Receives FDA Breakthrough Device Designation for its Neuroimmune Modulation... Mar 13, 2024 - SetPoint Medical Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for... fda breakthrough device setpoint medical receives https://www.biospace.com/press-releases/mursla-bio-receives-fda-breakthrough-device-designation-for-evoliver-test Mursla Bio Receives FDA Breakthrough Device Designation for EvoLiver Test - BioSpace fda breakthrough device bio receives https://www.prnewswire.com/news-releases/phantom-neuro-receives-fda-breakthrough-device-and-tap-designations-solidifying-position-as-a-neurotech-leader-302394079.html Phantom Neuro Receives FDA Breakthrough Device and TAP Designations, Solidifying Position as a... /PRNewswire/ -- Phantom Neuro, the neurotech company advancing human-machine interface, announces today that it has received two prestigious designations... fda breakthrough device https://www.prweb.com/releases/sonivie-receives-fda-breakthrough-device-designation-for-the-tivus-system-in-the-treatment-of-pulmonary-arterial-hypertension-pah--818390629.html SoniVie Receives FDA Breakthrough Device Designation for the TIVUS System in the Treatment of... /PRNewswire-PRWeb/ -- SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough... fda breakthrough device https://www.deccanherald.com/world/musks-neuralink-gets-fdas-breakthrough-device-tag-for-blindsight-implant-3195097 Musk's Neuralink gets FDA's breakthrough device tag for 'Blindsight' implant The FDA's breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. It is aimed at speeding up... fda breakthrough device musk neuralink gets https://www.businesswire.com/news/home/20220215005997/en/Rapid-Medical-Receives-FDA-Breakthrough-Device-Designation-for-Vasospasm-Treatment Rapid Medical Receives FDA Breakthrough Device Designation for Vasospasm Treatment Rapid Medical is granted FDA breakthrough designation for its Comaneci device, providing adjustable dilation to treat cerebral vasospasm. fda breakthrough device rapid medical receives designation https://www.businesswire.com/news/home/20200609005042/en/GTX-medical-Granted-FDA-Breakthrough-Device-Designation-for-Go-2-Targeted-Epidural-Spinal-Stimulation-TESS-System GTX medical Granted FDA Breakthrough Device Designation for Go-2 Targeted Epidural Spinal... GTX medical (GTX), today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its implantable Go-2 system... fda breakthrough device https://www.business-standard.com/content/press-releases-ani/rnt-health-insights-private-limited-receives-fda-breakthrough-device-designation-for-early-gastric-cancer-detection-tool-124053101662_1.html RNT Health Insights Private Limited Receives FDA Breakthrough Device Designation for Early Gastric... Chandigarh [India], May 31: RNT Health Insights Private Limited, a clinical stage medical diagnostics company, is pleased to announce that the U.S. Food and... fda breakthrough device https://www.biospace.com/noctrix-health-granted-fda-breakthrough-device-designation-for-wearable-restless-legs-syndrome-therapy Noctrix Health granted FDA Breakthrough Device Designation for wearable Restless Legs Syndrome... Jun 3, 2020 - Noctrix Health, Inc., a privately held medical device company announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device... fda breakthrough device https://www.businesswire.com/news/home/20251015749718/en/Scanogen-Receives-FDA-Breakthrough-Device-Designation-for-Rapid-Bloodstream-Infection-Assay Scanogen Receives FDA Breakthrough Device Designation for Rapid Bloodstream Infection Assay Scanogen Inc. received FDA Breakthrough Device status for its rapid assay that identifies bloodstream infection pathogens in just two hours. fda breakthrough device bloodstream infection receives https://www.businesswire.com/news/home/20221024006067/en/EndoStim-Receives-FDA-Breakthrough-Device-Designation-for-the-EndoStim-System-for-the-Treatment-of-Drug-Refractory-GERD EndoStim Receives FDA Breakthrough Device Designation for the EndoStim System for the Treatment of... EndoStim, a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophagea... fda breakthrough device for the receives https://www.globenewswire.com/news-release/2024/11/06/2975758/0/en/FDA-Grants-Breakthrough-Device-Designation-for-SeaStar-Medical-s-Selective-Cytopheretic-Device-for-Adults-Undergoing-Chronic-Dialysis.html FDA Grants Breakthrough Device Designation for SeaStar This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar... fda grants breakthrough device designation https://www.hmpgloballearningnetwork.com/site/eplab/press-release/fda-grants-orchestra-biomed-additional-breakthrough-device-designation FDA Grants Orchestra BioMed Additional Breakthrough Device Designation for AVIM Therapy Orchestra BioMed Press Release Press Release fda grants orchestra biomed additional https://www.businesswire.com/news/home/20250403363714/en/U.S.-FDA-Grants-Paige-Breakthrough-Device-Designation-for-AI-Application-that-Detects-Cancer-Across-Different-Anatomic-Sites U.S. FDA Grants Paige Breakthrough Device Designation for AI Application that Detects Cancer Across... Paige, a leader in next-generation AI technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designatio... https://www.prnewswire.com/news-releases/invenio-imaging-receives-fda-breakthrough-device-designation-for-ai-based-image-analysis-module-to-assist-physicians-in-the-evaluation-of-bronchoscopic-lung-biopsies-302290901.html Invenio Imaging Receives FDA Breakthrough Device Designation for AI-based Image Analysis Module to... /PRNewswire/ -- Invenio Imaging, a leader in intraoperative fresh tissue imaging and artificial intelligence (AI), announced today that the U.S Food and Drug... https://www.businesswire.com/news/home/20250709101924/en/U.S.-FDA-Grants-Artera-Breakthrough-Device-Designation-for-AI-Powered-Software-Transforming-Prostate-Cancer-Care U.S. FDA Grants Artera Breakthrough Device Designation for AI-Powered Software Transforming... Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug ... u s fda