Debiotech, a leading Swiss innovation company in the field of medical devices, announced today that the Versi™PD Cycler System, developed in close collaboration with its licensee Fresenius Medical Care, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
| LAUSANNE, Switzerland, April 26, 2022 /PRNewswire/ -- Debiotech, a leading Swiss innovation company in the field of medical devices, announced today that the Versi™PD Cycler System, developed in close collaboration with its licensee Fresenius Medical Care, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This home peritoneal dialysis device is the smallest, lightest, and quietest cycler in the United States today.
“This is a significant milestone in kidney replacement therapy that is being achieved today. It is also a great reward for all the team of Debiotech which has been working for many years to make such true innovation available to a greater number and broader range of patients living with kidney failure” says Frédéric Neftel M.D., President of Debiotech. “We are also proud to be closely associated to our license partner, Fresenius Medical Care, who has always been dedicated to a strong Patient support in the field of Renal Care, with a leading presence all over the world.” Resulting from a substantial development work, this device brings many innovations to dialysis patients and will allow a faster and wider deployment of home therapies. The user experience is, along with safety, a central element of the device’s design. An intuitive graphical user interface that includes video and audio guidance on a touch screen provides real support for patients during set-up and throughout treatment. Particular attention has also been paid to quality of life during treatment: thanks to the machine’s almost silent operation, a reduction in the number of disruptive alarms and the night mode, patients will be able to enjoy a better quality of sleep. Versi™PD allows a wide range of prescription programming to suit the specific needs of a very diverse patient population. Particular attention has been paid to the device’s handling. Its small size and light weight make it easy to carry around. A specific cart has also been designed to simplify mobility in the patient’s home. The cycler will be linked to the Kinexus™ Therapy Management Platform from Fresenius. This connected healthcare system will improve patient outcomes, potentially reduce hospital admissions and patient dropouts, while simplifying the nurse’s work and increasing productivity. “Versi™PD is a perfect example of the expertise of the company and its engineers. Small, easy to use, interconnected for maximum flexibility and support, and yet it is one of the most complex machines you can conceive in the medical device field” adds Laurent-Dominique Piveteau, CEO of Debiotech. Versi™PD will begin a limited rollout in 2022 with more widespread availability planned in 2023 and beyond. Debiotech is active for more than 30 years in the design of innovative medical devices improving Patient Quality of Life. Specialized in the realization of small devices, mostly used by patients themselves at home, the company has acquired a highly diversified expertise in integrated electromechanical systems as well as in software as and for medical devices. In particular, it is recognized for its expertise and know-how in remote patient monitoring and in the cyber security of medical devices. The company offers its services to large and small players in the medical field seeking to develop innovative devices in the most time effective manner while complying with EU and FDA regulation. Follow our activity on our website or on linked-in. For more information about VersiPD, please visit: https://fmcna.com/versipd For more information about Debiotech, please visit: https://www.debiotech.com Remi Charrier
SOURCE Debiotech SA |
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