MedTech Industry Dynamics
MedTech Industry Dynamics
Roche has received FDA clearance for its Elecsys pTau217 blood test, the first and only FDA-cleared single-biomarker test supporting both rule-in and rule-out assessment of amyloid pathology. Quest Diagnostics and Labcorp will offer the test to clinicians nationwide.
Per saperne di piùC2N Diagnostics has received FDA clearance for its PrecivityAD2 blood test, the first Alzheimer’s diagnostic aid cleared for use in symptomatic adults aged 40 and older, delivering high diagnostic performance to help clinicians rule in or rule out clinical Alzheimer’s disease.
Per saperne di piùEmpatica has received FDA 510(k) clearance for its Health Monitoring Platform for Parkinson’s, enabling continuous symptom monitoring through clinical-grade wearables to support personalized care and clinical research.
Per saperne di piùBeckman Coulter Diagnostics has received CE Mark under IVDR for its Access p-Tau217 blood test to support clinical evaluation of amyloid pathology in cognitive decline, while also launching a high-specificity brain-derived pTau217 research assay for neurodegenerative research.
Per saperne di piùTOBY has received FDA Breakthrough Device Designation for its urine-based Alzheimer’s disease diagnostic test, which uses urinary volatile organic compound patterns analyzed through mass spectroscopy and machine learning to aid in diagnosis through a simple, non-invasive sample.
Per saperne di piùNeuroVision Imaging has acquired Durin Life Sciences, combining blood-based biomarker tests, retinal imaging technology, and a telehealth platform to support earlier detection and longitudinal care for Alzheimer’s, Parkinson’s, and other neurological disorders.
Per saperne di piùSiemens Healthineers has introduced new blood-based biomarker assays for brain health research, aiming to support studies on neurological diseases and reduce reliance on invasive diagnostic methods.
Per saperne di piùCognito Therapeutics has secured $105 million in oversubscribed Series C financing to support clinical development and regulatory plans for Spectris, an investigational at-home neurotechnology therapy for Alzheimer’s disease.
Per saperne di piùSiemens Healthineers will co-lead the five-year EU-funded ACCESS-AD initiative, aiming to improve Alzheimer’s diagnosis, treatment access, and real-world evidence generation across Europe.
Per saperne di piùMMI has received FDA approval for an Investigational Device Exemption to launch REMIND, the first clinical study evaluating robotic-enabled microsurgical intervention for Alzheimer’s disease.
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