4DMedical, a global technology company and producer of advanced lung function imaging software, has received U.S Food and Drug Administration (FDA) clearance for its CT-based ventilation product (CT LVAS), according to a company statement released Nov. 22 ahead of the Scientific Session and Annual Meeting of the Radiological Society of North America, RSNA 2023, being held in Chicago, IL.
November 25, 2023 — 4DMedical, a global technology company and producer of advanced lung function imaging software, has received U.S Food and Drug Administration (FDA) clearance for its CT-based ventilation product (CT LVAS). CT LVAS, designed for use with computed tomography scans, joins 4D Medical's XV LVAS imaging software cleared for use with fluoroscopy in the United States. The FDA clearance for CT LVAS dovetails with the upcoming 4DMedical product, CT:VQ, which will enable quantitative perfusion (blood flow) data and visualizations to be extracted from CT scans.
Standard CT images provide clinicians with structural detail about patients' lungs—from which they try to infer information about disease and function. CT LVAS adds a wealth of data on lung performance on top of the structural detail of CT scans. This capability fills an information gap that enables radiologists to provide the objective, data-driven information that could materially inform diagnosis and treatment options.
"Having assisted with image interpretation of CT LVAS exams in Australia, I've seen the diagnostic power of adding functional assessment to the structural information provided in standard non-contrast chest CTs,” said Greg Model, MD, consultant radiologist at 4D Medical. He added, “CT LVAS allows radiologists to provide a whole new dimension of lung health information to referring clinicians needing answers.” He further noted that he anticipates sharing the technology during the upcoming Radiological Society of North America Scientific Assembly and Annual Meeting, RSNA 2023.
CT LVAS software processes existing CT scans using sophisticated algorithms derived from aerospace technology. These highly detailed reports include color-coded images of regional airflow and lung ventilation—overlayed on the patient's CT scan. CT LVAS uses a software-as-a-service model and requires no new capital equipment. Scans from existing CT equipment are uploaded for processing, where they are analyzed and returned to the radiologist as the Ventilation Report.
Additionally, reports the company, CT LVAS measures lung ventilation in tens of thousands of locations in the lungs. The Regional Ventilation Visualizations provide region-specific ventilation at deep inspiratory breath-hold for a mid-coronal slice and three axial slices — Upper, Middle, and Lower. The regional ventilation data is quantified in lung volume change and regional lung ventilation heterogeneity.
"I am excited by the impact CT LVAS will provide caregivers and patients in the U.S." says 4DMedical Founder and CEO Andreas Fouras. "As we head to RSNA, I am thrilled that reimbursement has been approved for our XV LVAS product designed for fluoroscopy, and to also share FDA clearance for CT LVAS in the U.S. We also look towards the commercial release of CT:VQ and the opportunity to combine and provide the two sets of highly quantified lung pulmonary information from CT LVAS and CT:VQ.
In healthy lungs, ventilation and perfusion are well-matched, meaning that airflow and blood flow are equally distributed throughout the lungs. 4DMedical's CT:VQ technology will enable regional changes in ventilation and perfusion to be quantified and visualized, allowing a detailed assessment of V/Q mismatch. Clinically, these scans will primarily be used for diagnosing pulmonary embolism, but they can also be employed to assess conditions such as chronic obstructive pulmonary disease, pulmonary hypertension, and to evaluate pulmonary vascular disorders.
Importantly, perfusion (blood flow) data and visualizations from CT:VQ can be combined with the ventilation data and visualizations provided by CT LVAS--for a highly quantified picture of lung performance.
4DMedical Limited is a global medical technology company that has created a step change in the capacity to accurately and quickly understand the lung function of patients with respiratory diseases. The company notes that through its flagship patented XV Technology, 4DMedical enables physicians to understand regional airflow in the lungs and identify respiratory deficiencies earlier and with greater sensitivity as they breathe. This technology powers 4DMedical's FDA-cleared XV Lung Ventilation Analysis Software (XV LVAS) — the first modality to dynamically quantify ventilation throughout the lungs, and its FDA-cleared Computed Tomography-enabled counterpart software, CT LVAS. XV LVAS and CT LVAS reports are prepared using 4DMedical's Software as a Service delivery model using existing clinical imaging equipment or the Company's revolutionary XV Scanner.
More information: www.4dmedical.com
Find and follow more of ITN's RSNA23 news conference coverage here