Koru Medical Systems has secured regulatory clearance in Japan for its FreedomEdge infusion system.
The system is now approved for the administration of several drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Sobi’s Aspaveli paroxysmal nocturnal haemoglobinuria (PNH), and Takeda Pharmaceutical’s Cuvitru SCIg.
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The clearance of the FreedomEdge system in Japan is expected to enhance the quality of care for patients by providing a precise method for administering subcutaneous immunoglobulin and other large-volume therapies.
It is designed to allow usage both at home and in clinical settings.
Designed to be patient-centric, the FreedomEdge system offers customisable features to cater to individual treatment needs.
Its portability and ease of use are expected to empower patients with greater control over their therapy management.
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By GlobalDataKoru Medical president and CEO Linda Tharby said: “We are very pleased to have received regulatory clearance for the FreedomEdge System in Japan.
“This accomplishment underscores our commitment to advancing healthcare solutions that enhance patients’ lives worldwide and further strengthens Koru’s expansion into international markets.
“With the approval of the FreedomEdge System in Japan, we are proud to broaden access to critical therapies, empowering patients and healthcare providers with a reliable and user-friendly drug delivery platform.”
Last year, Koru submitted a 510(k) premarket notification to the US Food and Drug Administration for its FREEDOM60 syringe infusion system with Hizentra prefilled syringes.
