Mindshare Medical announces CE Mark for RevealAI-Lung: The first AI-based solution for radiology diagnostics cleared in Europe
15 Jul, 2019, 08:00 BST
SEATTLE, July 15, 2019 /PRNewswire/ -- Mindshare Medical announced today that its RevealAI-Lung product has been cleared for sale in Europe (CE Mark) for use with CT scans of the lung.
The product, a Computer Assisted Diagnostic (CADx) software for lung cancer diagnosis, is the first diagnostic platform to gain regulatory clearance in its class. RevealAI-Lung can significantly improve clinicians' diagnostic efficacy and optimize recommendations for follow-up, while integrating seamlessly with existing Picture Archiving and Communication Systems (PACS).
Mindshare has demonstrated the potential for reducing both false-positives and time to diagnosis, which may reduce patient exposure to unnecessary imaging procedures and biopsy in some cases, while also providing the opportunity to treat lung cancer at an earlier stage.
Lung cancer is the leading cause of death among men and women worldwide with 376,000 deaths in Europe in 2017, which represents 20% of all cancer deaths. It also accounts for the loss of 3.2 million disability-adjusted life-years annually.
Taking into account Europe's 5-year net survival rate of 18%, the ability to intercept and treat a malignant nodule even a few months earlier could yield significant benefit to patients. In addition to these clinical advantages, when considering the financial burden to the healthcare system, reducing the unnecessary procedures from false-positives yields substantial cost-savings. Mindshare's RevealAI can play a key role in the adoption of value-based health care and increase the implementation of lung cancer screening programs throughout Europe.
"We at Mindshare are very pleased to bring RevealAI to the European market as the first cleared CADx product. Our partners in the UK and across the continent have recognized the value that Mindshare can bring for managing lung nodules. From radiology to thoracic surgery, there are broad implications, and we're excited about delivering this benefit to help patients and help healthcare systems deliver care."
Michael Calhoun, PhD. CEO, Mindshare Medical
Mindshare Medical develops revolutionary, evidence-based clinical decision support technologies that provide personalized diagnostics and guidance for more effective follow-up procedures and treatments. This precision medicine radiomics approach is intended to dramatically optimize patient outcomes and reduce the financial burden for health care organizations. Mindshare's solutions are designed to fit within existing clinical workflows - delivering impactful insights at the clinician's fingertips.
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SOURCE Mindshare Medical