Quanta receives FDA clearance for home hemodialysis
Quanta, a portfolio company headquartered in Massachusetts, received FDA clearance for their at-home Quanta Dialysis System, becoming the only company to off a high dialysate flow system across the entire USA care continuum for end stage renal disease (ESRD) patients.
This follows another significant recent milestone in which the company received clearance for the first, and only, FDA-cleared device able to perform intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED), and CRRT (CVVHD and SCUF) without any need for bags.
Alejandro Galindo, CEO, Quanta Dialysis SolutionsThe 510(k) clearance embodies the hard work and determination of our exceptional team at Quanta. We recruited and executed this pivotal trial during the height of COVID-19 and have now achieved an FDA clearance few other products have obtained. As the US continues to evolve towards value-based care models, the focus for patients with chronic diseases is on minimizing complications and re-admissions.
Our product is designed to help those patients seamlessly transition to the home and remain there as long as possible. We are currently planning our home launch with customers who have successfully implemented Quanta into acute and sub-acute settings first.
Dr. Paul Komenda, CMO, QuantaMany patients prefer the flexibility of home hemodialysis – a flexible schedule, no commute, and with more frequent therapies they feel better and need less medication. Expanding treatment into the home is something we are constantly asked about by clinicians, advocacy groups, providers and patients. One of our major commitments as a business is to make kidney care more accessible, and with an easy-to-train, easy-to-maintain device that accommodates a high-flow HD prescription, Quanta is poised to become the best option for the home.
About Quanta Dialysis System
As a compact device with performance comparable to larger traditional machines, the Quanta Dialysis System provides the clinical versatility needed to deliver kidney replacement therapy across multiple care settings. With an intuitive user interface and only once-weekly hot rinse requirement, the device is designed to be operated by a broad range of users to bring dialysis directly to patients.
The Royal Academy of Engineering announced Quanta Dialysis Technologies as the recipient of the 2022 MacRobert Award (the UK’s longest running and most prestigious award for UK engineering innovation), joining the ranks of Rolls-Royce, Arup and Raspberry Pi.
To learn more about Quanta and its products, visit www.quantadt.com.
Learn more about Quanta Dialysis Technologies