Aidence, a startup developing medical imaging diagnostic software based on deep learning, announces that it has received CE Mark level IIa regulatory approval for its Veye Lung Nodules solution for pulmonary nodule detection on chest CT. Veye Lung Nodules is now cleared for clinical use across the EU.
‘Lung cancer screening with low-dose CT can save lives’, according to a recent policy paper in Lancet Oncology of November 2017.
Early detection of pulmonary nodules is very important for managing early-stage lung cancer and maximizing survival rates. Veye Lung Nodules addresses this difficult and time-consuming task by assisting the radiologist with the automated detection of suspicious lesions. It combines high accuracy with a low false positive rate and seamless integration into the radiologist’s workflow for maximum efficiency.
Lung Nodules meets the acute need for radiologists to find a better way to manage their pulmonary nodule workload. Time pressure, a shortage of radiologists in many countries and increasingly detailed clinical guidelines necessitate the use of specialized software. The introduction of deep learning in Veye Lung Nodules makes this possible for the first time without a separate user interface and with full integration into the reading process.
Mark-Jan Harte, Aidence CEO:
“We are very proud to receive one of the first level II certifications for deep learning-based medical software. This certification means that our software is approved for clinical use as part of the diagnostic process. Veye Lung Nodules can now be used in screening and routine clinical practice. Our goal is to make the management of early-stage lung cancer more cost-effective and accurate as well as faster. This CE marking brings us a big step closer to achieving it.”
Several hospitals in the Netherlands are currently testing Veye Lung Nodules; the CE mark will accelerate the uptake in clinical practice in the UK, Sweden, Denmark, and other European countries.