Friday, 15 November 2019

HSA approved Histoindex’s stain-free digital pathology system

11 January 2018 | Regulatory

Laennec digital pathology imaging system is to support pathologists for the diagnosis of liver fibrosis and other chronic liver diseases

HistoIndex is a technology spin-off company from the Institute of Biotechnology and Nanotechnology (IBN), Agency of Science, Research and Technology, Singapore. 

MedTech innovator Histoindex Pte. Ltd. designed the stain-free Laennec digital pathology imaging system to aid pathologists in the clinical diagnosis of liver fibrosis and other chronic liver diseases. 

The company has achieved its first regulated in vitro diagnostics (IVD) product status with the issuance of a Health Sciences Authority (HSA) Class A licence. 

This is a world’s first achievement for a stain-free digital pathology innovation to be approved for use in a clinical diagnosis setting. 

Pathologists in Singapore can now rely on Laennec to efficiently and accurately carry out their diagnostic procedures for liver fibrosis, particularly Nonalcoholic steatohepatitis (NASH), which is a severe form of Nonalcoholic fatty liver disease (NAFLD).

HistoIndex is currently in discussion with public hospitals and laboratories in Singapore to implement the Laennec imaging system as part of their pathology workflow. 

Also, as part of HistoIndex’s globalisation strategy, the company is on track for the China Food and Drug Administration (CFDA) regulatory approval by Q3/Q4 2018 and has been exploring various partnership opportunities with hospitals in China that will greatly benefit from having Laennec in their pathology laboratory.

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