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ASI bladder cancer imaging system wins FDA nod

Applied Spectral Imaging (ASI) has received the US Food and Drug Administration (FDA) clearance for its GenASIs Scan & Analysis, SpotScan.

GenASIs Scan & Analysis, SpotScan is used as a diagnostic aid for the detection of chromosomal aberrations in bladder cancer.

The cells of interest are targeted based on color size and their signals pattern facilitates in the diagnosis of bladder carcinoma in patients with hematuria.

GenASIs Scan & Analysis also assists in the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

ASI said with the launch of its new GenASIs Scan & Analysis, it has expanded its FDA cleared portfolio and now provides 3 major FDA cleared computerized diagnostic aids for: breast cancer – HER2/neu, CEP XY for counting and classifying fluorescent signals in interphase nuclei and the newly cleared UroVysion test for the detection of cells in urine specimens.

UroVysion is used for the detection of cells in urine specimens, stained with fluorescence in situ hybridization (FISH) using Vysis UroVysion Bladder Cancer Kit.

Suncoast Pathology Associates MD, president and CEO Felipe Dominguez said the combined microscope and computer-aided image analysis capabilities of GenASIs help them give faster and more accurate clinical results.

"GenASIs takes automated UroVysion scanning and analysis to a new level," Dominguez said.

ASI CEO Limor Shiposh said they plan to expand their portfolio of FDA cleared tools in their GenASIs platform to better serve their customers in achieving more accurate clinical results, quicker and more cost effectively.