PneumaCare Ltd recently announced that it has received 510(k) clearance from the US FDA for its Thora-3DI imaging device. According to a PneumaCare news release, 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 SLP technology utilizes safe white light to project a grid pattern onto the chest and accurate 3D images of chest wall movements over time. The measurements are then converted into visual and numerical outputs and continually monitor patients in real time without direct patient contact or intervention.
The technology can be used to measure the respiratory status in patients with an array of conditions, such as pneumonia, lung failure, COPD, and asthma. The PneumaCare news release indicates that the Thora-3DI is mobile and can be moved between wards or dismantled for transport and use in clinics or the community. The device is intended for hospital and clinical use.
“We are delighted to receive FDA approval for our revolutionary product, which brings benefits for doctors and patients alike. Thora-3DI is a first-in-class product that will be of wide interest to respiratory physicians worldwide. 510(k) clearance builds on the success of our CE mark authorization for the product in Europe, achieved in 2012,” says PneumaCare CEO Mark Harwood. “A number of clinical trials continue to demonstrate major benefits of respiratory assessment using the Thora-3DI, and publication of trial data are in progress. We believe that these results will have significant implications for patient care in a range of clinical areas.”
The bench and clinical validations required for the FDA 510(k) clearance demonstrated that this system can detect movements as small as 0.25 mm, and can accurately measure respiratory rate to within less than one breath per minute when compared with the FDA gold standard reference device, as indicated on the PneumaCare news release.
Bill Mason, MD, chairman of PneumaCare, says, “The Company has met and surpassed the stringent criteria imposed by FDA for clearance to market medical technology, through a process that has taken nearly two years of hard work and intense consultation with the regulatory authority. I am very proud of our team for attaining this major achievement and also extend much gratitude to our shareholders, who have supported the company throughout the development of this innovative approach to an unmet clinical need.”