Envisionit receives FDA clearance for Radify system

AuntMinnie.com staff writers
Jan 25, 2024

Envisionit Deep AI has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's AI-assisted chest x-ray system, Radify.

The system has been cleared for triaging pneumothorax and pleural effusion. The company highlighted that Radify showed high accuracy in triaging both pathologies, within an average of three seconds to alert healthcare professionals.

Envisionit added that the system was evaluated using diverse data and subgroup analysis through Ratify, a standalone AI Validation and Quality Assurance tool in the company’s product suite.

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Features extracted from lateral radiographs. (a) thoracic kyphosis and lumbar lordosis (b) proximal thoracic kyphosis (c) mid-lower thoracic kyphosis (d) thoracolumbar lordosis angle measured between the superior endplate and the inferior endplate of the vertebral levels: T2-T12, L1-L5, T2-T5, T5-T12, and T12-L2. Image courtesy of PLOS One.
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