The FDA approval enables manufacturing of the cartridges in North America, which localises production, reduces cost and mitigates supply chain risks
Outset Medical has obtained the US Food and Drug Administration (FDA) 510(k) clearance for a new method to sterilise cartridges used in its Tablo Hemodialysis System.
The single-use disposable cartridge works with the console of Tablo system to deliver dialysis treatment and is said to simplify treatment set-up and take-down.
With the FDA approval, the medical technology company is enabled to commence the full production of Tablo cartridge, through a manufacturing partner in Mexico.
Producing cartridges in a new location would localise production, eliminate air freight delivery, which is expensive and simplify the distribution and logistics, said the company.
Outset president and CEO Leslie Trigg said: “This clearance is an important milestone on our roadmap to continued gross margin expansion.
“In addition to cost reduction, we also are now better able to optimise our manufacturing process and mitigate current supply chain challenges around lead time, capacity and logistics.”
Also, the FDA approval would enable the company to start using an environment-friendly cartridge sterilisation method.
E-beam is a non-ionising technology designed to be produced on-demand and does not involve toxic or potentially explosive chemicals.
Outset is a medical technology company focused on developing advanced technology that reduces the cost and complexity of dialysis.
Its Tablo Hemodialysis System is a compact 35-inch unit with an integrated water purification technology, capable of delivering multiple dialysis treatment types.
Tablo is a connected and intelligent device, with two-way wireless data transmission capability with the cloud, and a unique data analytics platform.
It reduces the costs and complexity of dialysis, and allows remote monitoring of patients at home, to simplify the patient and provider experience, said Outset.
Tablo Hemodialysis System has been approved by the FDA, for use in the hospital and home.
Earlier this month, Tablo system has received the Centres for Medicare & Medicaid Services (CMS) approval for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES).
TPNIES is a programme recently enacted by CMS to enhance access to new and advanced medical technologies for end-stage renal disease (ESRD) patients.
The CMS decision is expected to encourage healthcare providers to adopt new technology that enables more patients to dialyse at home.