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LBT Innovations - US FDA 510(k) Clearance for MRSA Analysis Module


Australian medical technology company LBT Innovations Limited (ASX: LBT) (LBT or the Company), a leader in medical technology automation using artificial intelligence, is pleased to announce that the United States Food and Drug Administration (FDA) has given 510(k) clearance for the Company’s culture plate reading technology, APAS® Independence with associated MRSA analysis module.

Key Points:

• FDA clearance for APAS® Independence with MRSA analysis module as Class II medical device
• APAS® Independence now cleared for sale in the US with both Urine and MRSA analysis modules
• MRSA is a major healthcare issue – one of the leading causes of multi-drug resistant infections
• APAS® Independence value proposition now significantly enhanced for US customers

LBT’s 50% owned joint venture company, Clever Culture Systems (CCS) received 510(k) clearance for the APAS® Independence with MRSA analysis module as a Class II medical device, enabling the module to be sold commercially to customers in the United States.

MRSA, or Methicillin-resistant Staphylococcus aureus is one of the leading causes of multi-drug resistant infections and is a significant and growing healthcare issue in the United States and globally. Patients suffering from MRSA infections are 64% more likely to die than people with drug sensitive infections.

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