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Roche receives FDA clearance on its digital pathology solution for diagnostic use

Roche announced that its whole-slide imaging system, the Roche Digital Pathology Dx (VENTANA DP 200), has received 510(k) clearance from the United States Food...

Healthcare

FDA Approves Genentech’s Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer

This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant...

Healthcare

Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer’s disease diagnosis

Roche announced that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This blood test, which is...

Healthcare

Prenosis Announces Commercial Distribution Collaboration With Roche For Sepsis Immunoscore™, The First FDA De Novo Authorized Artificial Intelligence Tool For Sepsis Detection

Prenosis will collaborate with Roche to bring the Sepsis ImmunoScore™ to hospitals across the United States on Roche's navify® Algorithm Suite platform Prenosis, Inc., an artificial intelligence company enabling precision...

Healthcare

Roche enters into collaboration agreement with PathAI to expand digital pathology capabilities for companion diagnostics

Roche announced that it has entered into an agreement with PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology. Under the terms of...

Healthcare

Roche expands hepatitis diagnostics portfolio to help clinicians diagnose and monitor patients with acute or chronic hepatitis B infection

Roche announced the launch of Elecsys HBeAg quant, an immunoassay that is able to determine both the presence and quantity of the hepatitis B...

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