4D Medical achieves FDA clearance for CT LVAS, a game-changing CT-based ventilation software complementing its XV LVAS. This advanced technology, showcased at RSNA 2023, enriches CT scans with detailed functional insights, empowering radiologists to deliver precise diagnoses and treatment plans. CT LVAS processes existing CT scans via aerospace-derived algorithms, providing comprehensive ventilation reports overlaying color-coded visuals onto patient scans. The upcoming CT:VQ promises quantified perfusion and ventilation data, enabling in-depth assessments. Integration of CT LVAS and CT:VQ offers a highly quantified lung performance representation. 4D Medical revolutionizes respiratory healthcare through cutting-edge imaging solutions.
4D Medical, a global pioneer in advanced lung function imaging software, has recently obtained clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking CT-based ventilation product, CT LVAS. This innovative software, designed to operate seamlessly with computed tomography scans, marks a significant leap in the realm of lung imaging technology. It complements the company’s previously cleared XV LVAS imaging software, intended for use with fluoroscopy in the United States. The FDA’s nod for CT LVAS aligns perfectly with 4D Medical’s imminent product, CT:VQ, promising quantitative perfusion (blood flow) data extraction and visualizations from CT scans.
While traditional CT images provide structural insights into patients’ lungs, CT LVAS introduces an abundance of data on lung functionality atop the structural details captured by CT scans. This augmentation fills a critical information void, empowering radiologists to offer objective, data-driven insights that can significantly impact diagnosis and treatment decisions.
Dr. Greg Model, a consultant radiologist at 4D Medical, emphasized the diagnostic potency of incorporating functional assessments alongside structural information from standard non-contrast chest CTs. “CT LVAS allows radiologists to offer an entirely new dimension of lung health information to referring clinicians seeking precise answers,” he stated. Dr. Model eagerly anticipates showcasing this technology at the upcoming Radiological Society of North America Scientific Assembly and Annual Meeting in 2023.
The CT LVAS software leverages sophisticated algorithms derived from aerospace technology to process existing CT scans, generating highly detailed reports comprising color-coded images showcasing regional airflow and lung ventilation. These visuals overlay onto the patient’s CT scan, providing a comprehensive Ventilation Report to radiologists. Notably, this software operates on a software-as-a-service model, necessitating no additional capital equipment. Existing CT scans are simply uploaded for processing, analyzed, and then returned to radiologists as comprehensive reports.
Furthermore, the CT LVAS system conducts lung ventilation measurements across tens of thousands of locations within the lungs. The Regional Ventilation Visualizations offer specific ventilation details for various lung regions, including deep inspiratory breath-hold data for a mid-coronal slice, as well as upper, middle, and lower axial slices. These visualizations quantify regional lung volume changes and ventilation heterogeneity.
Andreas Fouras, the Founder and CEO of 4DMedical, expressed his excitement about the potential impact of CT LVAS on caregivers and patients in the United States. “As we approach RSNA, I am delighted about the approved reimbursement for our XV LVAS product meant for fluoroscopy and the FDA clearance for CT LVAS in the U.S.,” he remarked. Fouras also highlighted the impending commercial release of CT:VQ and the opportunity to integrate and provide highly detailed pulmonary information derived from both CT LVAS and CT:VQ.
The upcoming CT:VQ technology by 4DMedical aims to precisely quantify and visualize regional changes in both ventilation and perfusion, enabling a meticulous assessment of V/Q mismatch. Primarily utilized in diagnosing pulmonary embolism, these scans also hold potential in assessing conditions like chronic obstructive pulmonary disease, pulmonary hypertension, and evaluating pulmonary vascular disorders.
Crucially, CT:VQ’s perfusion data and visualizations can be merged with CT LVAS’s ventilation data and visualizations, resulting in a comprehensive and highly quantified representation of lung performance.
4DMedical Limited stands as a global medical technology company revolutionizing the accurate and swift understanding of lung function among patients with respiratory ailments. Through its flagship patented XV Technology, the company empowers physicians to discern regional airflow in the lungs and identify respiratory deficiencies with greater sensitivity and earlier detection as patients breathe. This technology drives 4DMedical’s FDA-cleared XV Lung Ventilation Analysis Software (XV LVAS), the pioneering modality dynamically quantifying ventilation throughout the lungs. Additionally, the company’s FDA-cleared CT LVAS, enabled by computed tomography, operates via their Software as a Service delivery model using existing clinical imaging equipment or the Company’s innovative XV Scanner.
4D Medical’s FDA clearance for CT LVAS marks a significant stride in lung imaging, complementing its XV LVAS. This innovation empowers radiologists with unparalleled functional insights derived from existing CT scans. The company’s upcoming CT:VQ promises advanced perfusion and ventilation data, further enriching diagnostic capabilities. The integration of CT LVAS and CT:VQ ensures a highly detailed and quantified representation of lung health. With these cutting-edge imaging solutions, 4D Medical reshapes respiratory healthcare, providing clinicians with precise tools to diagnose and treat respiratory conditions effectively.