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Sibel Health’s AI-powered wearable reduces nighttime scratching in itchy patients

CHICAGO, Feb. 6, 2025 /PRNewswire/ — Sibel Health, an award-winning medical technology company that develops advanced wearable sensors, software, and AI/ML algorithms for clinical trials and clinical care, is pleased to announce a major peer-reviewed publication, “Artificial Intelligence-Enabled Wearable Devices and Nocturnal Scratching in Mild Atopic Dermatitis,” in JAMA Dermatology. This research describes a groundbreaking digital health technology designed to measure and reduce nighttime scratching in people with mild atopic dermatitis.

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Beckman Coulter Receives FDA Breakthrough Device Designation for Alzheimer’s Disease Blood Test

BREA, Calif., Jan. 28, 2025 /PRNewswire/ — Beckman Coulter Diagnostics, a global leader in clinical diagnostics, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Beckman Coulter’s Access p‑Tau217/β-Amyloid 1-42 plasma ratio. This blood test is designed to aid healthcare providers identify patients with amyloid pathology associated with Alzheimer’s disease.

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Spear Bio Secures FDA Breakthrough Device Designation for its Novel pTau 217 Blood Test, Advancing Scalable Solutions for Early Alzheimer’s Disease Diagnosis

WOBURN, Mass., Jan. 13, 2025 /PRNewswire/ — Spear Bio Inc., a biotechnology company pioneering next-generation ultra-sensitive immunoassays, today announced that its pTau 217 blood test has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This recognizes the test’s potential to address a critical unmet need for the millions of Americans living with Alzheimer’s disease and not yet diagnosed.

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