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Medical Devices / Submissions and Approvals

Innovus’ Glucose Monitoring Kit Gains FDA Approval

April 16, 2018

Innovus Pharmaceuticals received 510(k) clearance from the FDA for its GlucoGorx glucose monitoring kit for use in managing diabetes.

The kit can provide glucose level test results within four seconds, according to the company.

The test kit includes a glucose meter, lancet device and test strips and is eligible to enter reimbursement and government supply programs.

Innovus plans to launch the test kit later this year.

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