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https://www.medtechdive.com/news/roche-eli-lilly-fda-breakthrough-alzheimers-blood-test/713011/ Roche scores FDA breakthrough status for Alzheimer’s blood test | MedTech Dive The plasma assay is intended to aid in finding amyloid pathology, a biomarker of Alzheimer’s disease. fda breakthrough blood test roche scores status https://www.medtechdive.com/news/ai-diagnostic-tool-for-kidney-disease-earns-breakthrough-status/554022/ AI diagnostic tool for kidney disease earns breakthrough status | MedTech Dive The technology uses electronic health record information and machine learning algorithms to assess blood-based biomarkers and identify patients at risk for... diagnostic tool kidney disease breakthrough status ai earns https://www.medtechdive.com/news/Medtronic-AI-robotics-hub-London-Virtuoso-breakthrough-bladder/761041/ Medtronic expands AI, robotics hub in London; Virtuoso robot gets FDA breakthrough status | MedTech... The Medtronic center will facilitate surgeon collaboration and AI-powered decision support. At Virtuoso Surgical, a robotic approach to bladder lesion removal... expands ai gets fda breakthrough status medtronic robotics https://www.medtechdive.com/news/rapid-test-for-brain-injury-gets-fda-breakthrough-status/548216/ Rapid test for brain injury gets FDA breakthrough status | MedTech Dive The test measures protein biomarkers released from the brain into the bloodstream after a head trauma, producing results in as little as 90 seconds. rapid test brain injury gets fda breakthrough status medtech https://www.medtechdive.com/news/eye-scan-to-detect-alzheimers-biomarker-gets-breakthrough-status/554537/ Eye scan to detect Alzheimer's biomarker gets breakthrough status | MedTech Dive Optina Diagnostics' retinal imaging platform uses artificial intelligence to detect amyloid plaques in the brain and is intended to improve diagnostic accuracy... breakthrough status eye scan detect alzheimer https://www.medtechdive.com/news/bio-techne-gains-breakthrough-status-for-liquid-biopsy-prostate-test/557096/ Bio-Techne gains breakthrough status for liquid biopsy prostate test | MedTech Dive The test analyzes a patient's exosomes to help doctors determine whether a prostate biopsy is needed in patients with an ambiguous PSA test result. breakthrough status liquid biopsy techne gains prostate https://www.medtechdive.com/news/device-that-extracts-brain-tumors-gains-fda-breakthrough-status/548103/ Device that extracts brain tumors gains FDA breakthrough status | MedTech Dive After yielding successful results in rats, the device is being redesigned for human use with the goal of obtaining approval to start trials by the end of the... brain tumors fda breakthrough device extracts gains https://www.medtechdive.com/news/b-braun-gets-breakthrough-status-for-paclitaxel-coated-balloon-catheter/560206/ B. Braun gets breakthrough status for paclitaxel-coated balloon catheter | MedTech Dive The device will be studied for use in treating patients with coronary artery disease who experience in-stent restenosis and could allow patients to avoid an... breakthrough status braun gets paclitaxel coated https://www.medicaldevice-network.com/news/fda-breakthrough-status-capitans-supraspacer-implant/ FDA grants breakthrough status to Capitan’s SupraSpacer implant May 1, 2026 - The FDA has awarded a breakthrough device designation for Capitan Orthopedics' SupraSpacer implant for patients with irreparable rotator cuff tears. breakthrough status fda grants implant https://www.medtechdive.com/news/ai-tool-for-cancer-diagnosis-wins-fda-breakthrough-status/550058/ AI tool for cancer diagnosis wins FDA breakthrough status | MedTech Dive Startup Paige.AI, through a licensing agreement with Memorial Sloan Kettering Cancer Center, is developing a portfolio of artificial intelligence-based... ai tool cancer diagnosis wins fda breakthrough status medtech https://www.medtechdive.com/news/military-focused-abdominal-trauma-foam-earns-fda-breakthrough-status/557936/ Military-focused abdominal trauma foam earns FDA breakthrough status | MedTech Dive The agency awarded the designation to Critical Innovations, a company developing technologies for individuals injured in combat. fda breakthrough military focused abdominal trauma