SigTuple, a medtech company that develops AI-powered digital microscopy solutions, announced that the US FDA has granted 510(k) clearance for its AI100 with Shonit (Peripheral blood smear application). This is the first clearance for an integrated hardware and AI medical device, as well as the first product in India to achieve this prestigious milestone in AI-assisted digital microscopy.

AI-assisted digital pathology is represented by SigTuple'sAI100 with Shonit, which digitally images a physical sample through a microscopic lens and AI models extract and classify each cell into more than 30 different cell types. Pathologists can now review these samples remotely, and AI automation significantly improves their efficiency. As a result, the same pathologist can handle a significantly greater number of samples, obviating the need for additional manual reviews.

Apurv Manjrekar, Chief Product Officer, SigTuple said,

“SigTuple AI100 with Shonit 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. AI100 with ShonitTM is the first integrated hardware and AI medical device, and the first product in AI assisted digital microscopy from India to obtain the US FDA 510(k) clearance. Even globally, US FDA clearances for digital microscopy products are few and far between. SigTuple thus finds its place among a handful of global elites to have achieved this milestone.”

Tathagato Rai Dastidar, Founder & CEO, SigTuple said,

“This is a watershed moment for us – to have the quality and efficacy of our product validated and approved by one of the most stringent medical regulatory authorities in the world. This opens multiple new doorways for us to expand internationally, and build a global medical technology company out of India. The process also gave us invaluable experience on how to navigate the regulatory pathways, and this will prove to be an asset as we take our upcoming products through the approval processes”