Will FDA Approve Koru Medical Syringe Infusion Solution?

The US FDA has received a $510,000 premarket notice from Koru Medical for their syringe infusion solution using prefilled syringes containing Hizentra.

The medical device, FREEDOM60, has been created to administer medications that work to treat immunodeficiency. The product can be applied in domestic, hospital, or ambulatory environments.

Back in April, the FDA signed off a 50 ml version of the ‘ready to use’ Hizentra syringes, which were produced by US based biopharmaceutical firm called CSL Behring.

Recently, the creation and development of syringe controls has grown increasingly prolific. This is because they are able to reduce mistakes and offer accurate fluid administration, hence growing in demand for therapies that require many repeat injections.

Koru Medical’s Chief Executive Officer, Linda Tharby, explained that their syringe system achieves “an 80% reduction in drug preparation tasks compared to vials.”

“With market data showing significant uptake, this submission is another innovation milestone that will further enhance the patient experience and potentially be an additional growth driver for home subcutaneous therapy.”

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