510k regulatory clearance for Leo Cancer Care's unique patient positioning system, Eve®, paves the way for a new approach to patient treatment
MIDDLETON, Wis., May 9, 2024 /PRNewswire/ -- Leo Cancer Care is delighted to announce that it has gained regulatory clearance for its revolutionary upright patient positioning system for delivering radiotherapy treatment to patients. This 510(K) clearance means that the Eve System can now be used to offer 'a more human' method of treating cancer patients.
The FDA ruling sees our upright technology gain 510k status* and clearance to offer the equipment to healthcare providers to treat their patients across the United States with immediate effect.
The patient positioning system enables cancer patients to receive radiation treatment seated in an upright position. The design is innovative compared to majority of radiotherapy devices today, with the patient positioning system being one part of the whole solution, but the part that holds the most potential and more importantly the patient.
Research has already shown that the approach is a more natural position for patients with evidence suggesting that this will contribute to less internal organ movement leading to more efficient delivery of radiotherapy.
Studies have also shown that patients prefer to be in the upright position, rather than lying down.
CEO of Leo Cancer Care, Stephen Towe welcomed the landmark ruling.
He said: "Leo Cancer Care has always promised a lot; a new paradigm for radiation therapy with huge potential benefits for patients across the globe."
"This regulatory clearance marks a turning point for the company and our ability to deliver on those promises. This will see clinical adoption of the upright treatment approach giving patients the choice they have been waiting for."
The FDA regulatory clearance for Leo Cancer Care's upright technology is a truly significant step in the company's evolution, and also in the way radiation therapy can now be delivered to patients.
"This will now go from a non-clinical research solution to a fully functioning clinical device, with clinical treatments possible," added Towe.
Towe said that with one device cleared, Leo Cancer Care has a comprehensive development pipeline to deliver further solutions within the upright technology paradigm.
Please note: The Leo Cancer Care patient positioning system has achieved 510(K) clearance for the US market. Marie, including our upright CT scanner, is not yet clinically available.
*Section 510(k) of the Food, Drug and Cosmetic Act (https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances) requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).
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