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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The new guidance concerns the technical assessment of certain devices under the IVDR, which is slated to come into force in May 2022.

The company's GSP Neonatal Creatine Kinase-MM kit measures the CK-MM protein and is the first test to help in newborn screening for Duchenne Muscular Dystrophy. 

On the heels of receiving CE marking, the firm is engaging with global distributors and preparing a submission to the FDA for US clearance.

The firm said that after its device is placed on the upper arm, blood collection usually takes between two and three minutes following the press of a button.

The company's Accu-Check SugarView app determines blood glucose ranges without a blood glucose meter by taking photos with a smartphone camera.