PCL’s AI-based diagnostic device ‘PCLOK II PREP UNIVERSAL’ was approved by the FDA

PCL’s AI-based diagnostic device ‘PCLOK II PREP UNIVERSAL’ was approved by the FDA: COMPANY / Reporter Kim Jisun / 2023-12-01 00:53:25

[Alpha Biz=(Chicago) Reporter Kim Jisun] PCL announced on the 30th that it received approval from the US Food and Drug Administration (FDA) for artificial intelligence (AI)-based diagnostic equipment 'PCLOK II PREP UNIVERSAL'.

This product is an equipment that improves the sensitivity and accuracy of on-site rapid diagnostic equipment (POCT) 'PCLOK II', which has already been approved in the United States. It is a single platform that integrates existing immunoanalysis and clinical chemistry.

It is characterized by the ability to diagnose various chronic diseases, cancers, viruses, and infections at once on the spot. It also has the potential to be used as a home medical device in the future due to its excellent accuracy and user convenience.

According to Frost & Sullivan, a US business consulting firm, the in vitro diagnosis market is expected to grow 6.9% annually from $99.22 billion in 2021 to $138.34 billion in 2026. By technology, clinical immunoanalysis (about $ 35.9 billion), molecular diagnosis (about $ 30.4 billion), and POCT (about $ 19.6 billion) are expected by 2025.

PCL expects the size of related markets to grow rapidly if chronic diseases such as obesity and diabetes that can be managed at home are added to the test items.