SigTuple, a medtech company that develops artificial intelligence (AI)-powered digital microscopy solutions, has received U.S. FDA 510(k) clearance for its device -- AI100 with Shonit (a peripheral blood smear application).

“Our product automates one of the last remaining pieces of manual processes in a clinical laboratory—that of microscopic review of blood samples to detect various diseases,” said Apurv Manjrekar, Chief Product Officer, SigTuple. This is the first integrated hardware and AI medical device, and the first product in AI assisted digital microscopy from India to obtain the clearance, said the company.

For all haematological disorders, such as blood cancers, infections, anaemia, and allergies, the microscopic examination of the peripheral blood smear (PBS) is the gold standard test, but microscopy today is predominantly a manual process, necessitating a highly skilled pathologist to be present on-site.

The device is the premier solution for AI-assisted digital pathology, wherein a physical sample is digitally imaged through a microscopic lens, and the AI models extract each cell and then classify it into over 30 different cell types.

The pathologists can review the samples remotely. Further, AI helps make the pathologist more efficient by automating most of the review. Thus, the same pathologist can now handle a much larger number of samples than she can currently, eliminating the need for an additional manual review.

According to Tathagato Rai Dastidar, founder and CEO of SigTuple, receiving the clearance will open multiple new doorways for them to expand internationally and build a global medical technology company outside of India.