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FDA 510(k) clearance granted to PneumaCare’s ground-breaking Thora-3DI™

 

Clinical courses

PneumaCare Ltd announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Thora-3DI™ imaging device.Thora-3DI™ is a non-invasive, non-contact device that uses a patented technology known as structured light Plethysmography (SLP) to measure breathing through detection of movement of the chest and abdomen.

The technology can be used to accurately measure respiratory status in patients with a wide range of respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), pneumonia and lung failure, and to assess patients before and after surgery.

The SLP technology uses safe white light to project a grid pattern onto the chest, and record accurate 3D images of chest wall movements over time. The measurements are converted into visual and numerical outputs, which can help clinicians to make faster diagnoses and treatment decisions, and continually monitor patients in real time, without direct patient contact or intervention. The Thora-3DI™ is mobile, and can easily be moved between wards, or dismantled for transport and use in the community or in clinics.

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