Diality receives FDA 510(k) clearance for Moda-flx hemodialysis system
Click Here to Manage Email Alerts
Key takeaways:
- Moda-flx is designed for patients with acute and/or chronic renal failure.
- The hemodialysis platform offers variable flow rate ranges.
Diality has received FDA 510(k) clearance for its Moda-flx Hemodialysis System for acute and/or chronic renal failure, according to a press release.
The approval marks “an incredible milestone in our mission of developing solutions to improve lives impacted by kidney disease,” Osman Khawar, MD, CEO of Diality, said in the release. “We believe this platform will represent a new paradigm in the treatment of kidney disease and will help reduce the burden of care for all kidney care stakeholders.”
Moda-flx is designed for patients with acute and chronic renal failure with or without ultrafiltration, according to the release. It can be used in acute, post-acute or chronic care settings.
According to the release, the compact device has variable flow rate ranges, integrated reverse osmosis water filtration and a graphical user interface, which may provide a customizable experience for each patient. Treatment options include hemodialysis, sustained low efficiency dialysis and prolonged intermittent renal replacement therapy, which must be administered under a physician’s prescription, the release noted.
Reference:
Diality receives FDA 510(k) clearance for its Moda-flx hemodialysis system. https://www.newswise.com/articles/can-drinking-alkaline-water-help-prevent-kidney-stones-not-likely-study-finds?sc=dwhr&xy=10007438. Published Aug. 6, 2024. Accessed Aug. 6, 2024.
Click Here to Manage Email Alerts