FDA Greenlights Milvue’s SmartChest, AI solution for Chest

TRIAGE OF PNEUMOTHORAX AND PLEURAL EFFUSION IN ADULTS AND TRANSITIONAL ADOLESCENTS 

Press Release, June 07, 2024

Milvue, a French specialist in medical imaging workflows and artificial intelligence, has received FDA clearance for its AI-based solution for chest x-rays (CXR), SmartChest.

Chest radiographs are the most common first-line imaging procedures for the screening of potentially critical conditions such as a pneumothorax and/or a pleural effusion. In the current context of an increasing radiologists’ workload, prioritization is a key factor. Examinations containing such critical findings are frequently hidden in the long worklist of radiologists, thus delaying the interpretation and diagnosis. 

Using advanced deep learning technology, the SmartChest solution is an image processing device intended to aid in prioritization and triage of pleural effusions and pneumothorax on chest X-rays. SmartChest automatically and immediately analyzes CXRs and accurately flags the examinations suspected for a pneumothorax and/or a pleural effusion that need to be read as early as possible by a radiologist.

This milestone embodies Milvue’s forward-looking vision and the opportunities the company seeks to provide to medical imaging professionals globally.

INTEGRATION TO THE PRACTITIONERS’ WORKSTATION

Thanks to a direct integration to the practitioners’ workstation, SmartChest notifies a designated list of clinicians of the availability of time-sensitive radiological medical images for review, thus facilitating prioritization.

ADULTS (OVER 21 YEARS OLD) AND TRANSITIONAL ADOLESCENTS

Our SmartChest solution is intended for frontal AP & PA views in Chest radiographs of adults (over 21 years old) and transitional adolescents (18 – 21 years old).

SmartChest is a class II medical device according to US regulations. Please Consult IFU (Instructions For Use) of the product for more information.

> Discover the details of SmartChest

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