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https://tajikistantechdaily.com/article/897204152-pathai-receives-u-s-fda-breakthrough-device-designation-for-pathassist-derm-an-ai-powered-pathology-solution-to-transform-dermatopathology-workflow PathAI Receives U.S. FDA Breakthrough Device Designation for PathAssist Derm, an AI-Powered... fda breakthrough device an ai pathai receives designation https://trangcongnghe.com/news/pr-newswire/95081-nextbiomedical-secures-fda-breakthrough-device-designation-for-innovative-resorbable-microsphere-nexsphere-f.html NEXTBIOMEDICAL Secures FDA Breakthrough Device Designation for Innovative Resorbable Microsphere... Pioneering a Paradigm Shift in Pain Treatment, Accelerating Global Market Expansion SEOUL, South Korea, March 6, 2025 PRNewswire -- NEXTBIOMEDICAL CO., LTD, a... fda breakthrough device secures designation innovative resorbable https://24x7mag.com/standards/fda-updates/stimdia-pdstim-system-receives-fda-breakthrough-device-designation/ Stimdia pdSTIM System Receives FDA Breakthrough Device Designation Mar 19, 2021 - The Stimdia pdSTIM system is designed to facilitate weaning patients from mechanical ventilation by reconditioning the diaphragm. fda breakthrough device system receives designation https://www.pharmafocuseurope.com/technotrends/augurex-life-sciences-receives-fda-breakthrough Augurex Life Sciences Receives FDA Breakthrough Device Designation for SPINEstat® Diagnostic Test... Augurex Life Sciences Corp., a developer of autoimmune diagnostic tests, has received Breakthrough Device Designation from the U.S. Food and Drug... fda breakthrough device life sciences diagnostic test receives designation https://www.americanhhm.com/technotrends/baebies-secures-fda-breakthrough-device-designation-finder Baebies Secures FDA Breakthrough Device Designation FINDER® for Heparin Monitoring Baebies has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its Anti-Factor Xa test developed for the FINDER® platform.... fda breakthrough device secures designation heparin monitoring https://djiboutiindustryreporter.com/article/897204152-pathai-receives-u-s-fda-breakthrough-device-designation-for-pathassist-derm-an-ai-powered-pathology-solution-to-transform-dermatopathology-workflow PathAI Receives U.S. FDA Breakthrough Device Designation for PathAssist Derm, an AI-Powered... The Djibouti Industry Reporter is an online news publication focusing on industries in the Djibouti: The best industries and services news from Djibouti fda breakthrough device an ai pathai receives designation https://www.patientcareonline.com/view/freenome-lung-cancer-blood-test-receives-fda-breakthrough-device-status Freenome Lung Cancer Blood Test Receives FDA Breakthrough Device Status | Patient Care Online Oct 15, 2026 - The US FDA granted breakthrough device status to Freenome’s investigational blood test designed to triage high-risk adults for lung cancer screening. cancer blood test fda breakthrough device patient care lung receives https://www.psychiatrictimes.com/view/prescription-digital-therapeutic-for-schizophrenia-receives-fda-breakthrough-device-designation Prescription Digital Therapeutic for Schizophrenia Receives FDA Breakthrough Device Designation |... Oct 14, 2026 - The device is currently under clinical trial investigation as an adjunct treatment to standard of care therapy for experiential negative symptoms of... fda breakthrough device digital therapeutic prescription schizophrenia receives https://diagnostics.roche.com/us/en/news-listing/2024/roche-granted-fda-breakthrough-device-designation-ptau217-blood-test-support-earlier-alzheimers-disease-diagnosis.html Roche granted FDA Breakthrough Device Designation for pTau217 blood test to support earlier... Roche announced today that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). fda breakthrough device blood test roche granted designation https://www.genesismedtech.com/genesis-medtech-announces-fda-breakthrough-device-designation-for-the-j-valve-transfemoral-system/ Genesis MedTech announces FDA Breakthrough Device designation for the J-Valve™ Transfemoral System... fda breakthrough device for the genesis medtech announces https://vascularspecialistonline.com/endologix-receives-fda-breakthrough-device-designation-for-chevas-system/?hilite=abdominal+aortic+aneurysm Endologix receives FDA Breakthrough Device designation for ChEVAS system Sep 1, 2026 - Endologix today announced the company’s ChEVAS (chimney endovascular aneurysm sealing) system has been granted a Breakthrough Device designation from the Food... fda breakthrough device receives designation chevas system https://www.diagnosticimaging.com/view/fda-breakthrough-device-designation-ai-cxr-triage-software-pneumomediastinum-lung-collapse FDA Issues Breakthrough Device Designation for AI CXR Triage Software for Pneumomediastinum and... Oct 16, 2026 - The CARE Chest X-Ray (CXR) Triage software reportedly bolsters consistent flagging of suspicious chest X-rays for lung collapse and pneumomediastinum across... fda issues breakthrough device designation https://www.businesswire.com/news/home/20210908005136/en/FDA-Grants-Madorra-Breakthrough-Device-Designation-Status-for-Treatment-of-Moderate-to-Severe-Vulvovaginal-Atrophy FDA Grants Madorra Breakthrough Device Designation Status for Treatment of Moderate to Severe... The FDA granted Madorra breakthrough device designation for its non-invasive device for subset of women with moderate to severe vulvovaginal atrophy. fda grants madorra breakthrough device https://spectraldx.com/fda-grants-spectral-breakthrough-device-designation-for-toraymyxin-pmx/ US FDA Grants Spectral Medical Breakthrough Device Designation for Toraymyxin™ (“PMX”) for the... Jul 11, 2022 - The FDA has granted Breakthrough Device designation for Toraymyxin™ (“PMX”), a hemoperfusion device that removes endotoxin, which can cause septic shock. us fda grants spectral medical breakthrough