510k regulatory
clearance for Leo Cancer Care's unique patient positioning system,
EveĀ®, 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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