KORU Seeks FDA Clearance for Drug Delivery System

MT Newswires Live

2025/12/31

KORU Medical Systems (KRMD) said late Tuesday it is seeking clearance from the US Food and Drug Administration for the use of its FreedomEDGE infusion system to subcutaneously administer Phesgo therapy for HER2+ breast cancer patients.

The medical technology company said it has filed a premarket notification to the FDA and expects a market entry upon clearance from the regulator.

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