HIT Consultant April 19, 2024
Fred Pennic

What You Should Know:

– Scopio Labs, a leader in digital cell morphology, has achieved a major breakthrough with FDA De Novo clearance for its Full-Field Bone Marrow Aspirate (FF-BMA) Application.

– The FDA clearance marks a pivotal moment, establishing the first-ever regulatory category for digital bone marrow aspirate analysis software in the US.

Bone Marrow Analysis: Crucial for Diagnosing Blood Disorders

Microscopic analysis of bone marrow samples, known as bone marrow cytology, remains a vital tool for diagnosing a wide range of blood disorders. Hematologic malignancies, a leading cause of global cancer burden, account for roughly 10% of all diagnosed cancers in the US. Bone marrow aspirates (BMAs) play a crucial role in diagnosing these and other...

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Topics: Apps, Digital Health, FDA, Govt Agencies, Technology
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