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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://aasm.org/bairitone-health-receives-fda-breakthrough-device-designation-for-somnar/ Bairitone Health receives FDA Breakthrough Device Designation for Somnar May 1, 2026 - Bairitone Health receives FDA Breakthrough Device Designation for Somnar, a sleep sonar sensor patch. receives fda breakthrough device health designation somnar https://www.medtechdive.com/news/fda-breakthrough-devices-orteq-archerdx-terumo-thermedical-helius-photopharmics/578562/ FDA Breakthrough Devices Program nears 300 designations | MedTech Dive The agency has tapped 50 devices so far this year, with recent nods to Orteq, Thermedical, ArcherDX, Helius, PhotoPharmics and Terumo. fda breakthrough devices program nears designations 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/foam-to-stop-abdominal-bleeding-gets-fda-breakthrough-nod/557158/ Foam to stop abdominal bleeding gets FDA breakthrough nod | MedTech Dive Gel-e's Life Foam product is designed to stabilize the patient in battlefield conditions or in a traumatic accident where life-threatening internal bleeding... gets fda foam stop abdominal bleeding https://www.medtechdive.com/news/test-for-parkinsons-wins-fda-breakthrough-designation/555703/ Test for Parkinson's wins FDA breakthrough designation | MedTech Dive Developer Amprion's research focuses on the alpha-synuclein protein as a potential biomarker of the disease. wins fda test parkinson breakthrough designation https://www.medtechdive.com/news/intrathecal-drug-delivery-system-wins-fda-breakthrough-designation/550270/ Intrathecal drug delivery system wins FDA breakthrough designation | MedTech Dive The accelerated review status follows Alcyone's announcement of a strategic collaboration with Roche to develop treatment options for patients with... drug delivery wins fda intrathecal system breakthrough https://www.medicaltubingandextrusion.com/category/regulatory/fda-breakthrough-designations/ FDA Breakthrough Designation Archives - Medical Tubing and Extrusion archives medical tubing fda breakthrough designation extrusion 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/pulmonary-arterial-hypertension-device-wins-fda-breakthrough-designation/562456/ Pulmonary arterial hypertension device wins FDA breakthrough designation | MedTech Dive Tel Aviv-based SoniVie's device is an ultrasound catheter inserted into the pulmonary artery in a right heart procedure to ablate nerves associated with... wins fda pulmonary arterial hypertension device https://www.medtechdive.com/news/eko-mayo-clinic-heart-failure-screening-fda-breakthrough-device/569401/ AI-based heart failure screening from Eko, Mayo Clinic earns FDA breakthrough nod | MedTech Dive Digital health company Eko is working with the Mayo Clinic on an algorithm to detect reduced left ventricular ejection fraction, an indicator for heart... ai based heart failure mayo clinic fda breakthrough screening https://www.medtechdive.com/news/medtronic-developing-fully-implanted-lvad-with-fda-breakthrough-support/566131/ Medtronic developing fully implanted LVAD with FDA breakthrough support | MedTech Dive Medtronic's HeartWare left ventricular assist device to treat advanced heart failure has lost ground to Abbott's HeartMate system, but its forthcoming tech... fda breakthrough medtronic developing fully implanted https://www.pharmafocusamerica.com/technotrends/fore-biotherapeutics-receives-fda-breakthrough FORE Biotherapeutics Receives FDA Breakthrough Therapy Designation for Plixorafenib in Brain Cancer FORE Biotherapeutics has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its investigational drug plixorafenib,... receives fda fore biotherapeutics breakthrough therapy 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 https://www.medtechdive.com/news/fda-breakthrough-devices-4dpath-lumicell-sommetrics-spiderwort-syntellix/589627/ Breast cancer tech among FDA's latest breakthrough nods | MedTech Dive Over the past month, designations for speedier review have also ranged from a migraine treatment to tissue regeneration tech for spinal cord injuries. breast cancer tech among fda latest https://sentante.com/news/sentante-accepted-into-fda-total-product-life-cycle-advisory-program-following-breakthrough-device-designation/ Sentante accepted into FDA Total Product Life Cycle Advisory Program following Breakthrough Device... TAP selection builds on September’s FDA Breakthrough Device Designation and formalises the next phase of... life cycle advisory program accepted fda total https://www.ipsen.com/fr/press-release/la-fda-americaine-accorde-la-designation-breakthrough-therapy-a-lipn60340-ict01-dipsen-dans-la-leucemie-myeloide-aigue-de-premiere-ligne-chez-les-patients-ineligible-3218133/ La FDA américaine accorde la désignation « Breakthrough Therapy » à l’IPN60340 (ICT01) d’Ipsen dans... la fda accorde breakthrough therapy https://www.medtechdive.com/news/fda-names-beta-bionics-pancreas-tech-a-breakthrough-device/568867/ FDA names Beta Bionics' pancreas tech a breakthrough device | MedTech Dive The Boston-based medtech's so-called bionic pancreas incorporates dosing algorithms to automatically control blood sugar levels. breakthrough device fda names beta bionics https://www.healthcaredive.com/news/cms-fda-unveil-speedier-medicare-coverage-pathway-for-breakthrough-devices/818328/ CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices | Healthcare Dive The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class III breakthrough medical devices. cms fda unveil medicare coverage https://www.bioqubeventures.com/bicara-therapeutics-announces-ficerafusp-alfa-granted-breakthrough-therapy-designation-by-u-s-fda-for-1l-hpv-negative-r-m-hnscc/ Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation by U.S. FDA... Dec 1, 2025 - Designation supported by results from multiple dose cohorts from the Phase 1/1b trial of ficerafusp alfa in 1L HPV-negative R/M HNSCC BOSTON, Oct. 13, 2025... therapeutics announces bicara alfa granted breakthrough https://www.medtechdive.com/news/cms-pitches-coverage-of-breakthrough-devices-in-tandem-with-fda-authorizati/583997/ CMS pitches coverage of breakthrough devices in tandem with FDA authorization | MedTech Dive The proposal follows years of AdvaMed lobbying for products awarded the special FDA designation to gain Medicare reimbursement upon clearance or approval. cms pitches coverage breakthrough devices https://farmaindustrial.com/noticias/fda-cms-proponen-via-revision-paralela-acelerar-acceso-breakthrough-devices/ La FDA y los CMS proponen una vía de revisión paralela para acelerar el acceso a los 'Breakthrough... Apr 28, 2026 - La FDA y los CMS proponen un sistema que acelera la revisión de dispositivos Breakthrough, permitiendo su acceso más rápido a los pacientes. La iniciativa... para acelerar la fda los cms https://www.ipsen.com/press-release/u-s-fda-grants-ipsens-ipn60340-ict01-breakthrough-therapy-designation-in-first-line-unfit-acute-myeloid-leukemia-3218133/ U.S. FDA grants Ipsen’s IPN60340 (ICT01) Breakthrough Therapy Designation in first line unfit Acute... first line fda grants breakthrough therapy https://www.americanhhm.com/technotrends/ge-healthcare-secures-breakthrough-fda-clearance GE HealthCare Secures Breakthrough FDA Clearance for Photonova Spectra Photon-Counting CT GE HealthCare has received 510(k) clearance from the U.S. Food and Drug Administration for its Photonova Spectra photon-counting CT system, marking a key step... ge healthcare fda clearance photon counting secures breakthrough 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