FDA Grants De Novo Clearance to Scopio Labs’ AI-Powered Bone Marrow Pathology Application for Blood Disorders and Cancer

1. Scopio Labs, a digital morphology provider, has received FDA De Novo clearance for its Full-Field Bone Marrow Aspirate™ (FF-BMA) Application.
2. This clearance marks a groundbreaking milestone, as it is the first-ever digital bone marrow aspirate application to receive FDA approval.
3. The AI-powered system analyzes bone marrow biopsies, which is crucial for diagnosing blood disorders and cancer.
4. The clearance was granted on April 17, 2024.

These facts highlight the significance of Scopio Labs' achievement in receiving FDA De Novo clearance for their AI-powered bone marrow pathology application, which will aid in the diagnosis and management of blood disorders and cancer.