Indian MedTech Startup SigTuple Receives FDA Clearance for AI100 with Shonit

SigTuple's AI100 with Shonit represents AI-assisted digital pathology. In this process, a physical sample undergoes digital imaging through a microscopic lens, and AI models are employed to extract individual cells and categorise them into more than 30 distinct cell types.

SigTuple, a medtech startup specialising in Artificial Intelligence (AI)-powered digital microscopy solutions, has received US Food and Drug Administration (FDA) clearance for its AI100 with Shonit, a peripheral blood smear application.

This development represents the first integrated hardware and AI medical device and the initial product in AI-assisted digital microscopy from India to obtain the coveted FDA 510(k) clearance.

SigTuple's AI100 with Shonit represents an advanced development in the field of AI-assisted digital pathology. This technology allows physical samples to be digitally imaged through a microscopic lens, with AI models extracting each cell and classifying them into over 30 different cell types.

Importantly, pathologists can now review these samples remotely, with AI automation significantly enhancing their efficiency. This innovation also helps the pathologists to handle a much larger number of samples, eliminating the need for additional manual reviews.

Tathagato Rai Dastidar, founder & CEO of SigTuple, emphasised the validation of the product's quality and efficacy by one of the world's most stringent medical regulatory authorities. Dastidar also pointed out the broader implications, as it opens numerous opportunities for international expansion, paving the way for SigTuple to become a global medical technology company rooted in India.

Additionally, the startup said this regulatory experience equips SigTuple with valuable insights for navigating future regulatory pathways and obtaining approvals for upcoming products.

Apurv Manjrekar, chief product officer at SigTuple, highlighted the transformative potential of AI100 with Shonit, saying, "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."

He further noted that this achievement places SigTuple among a select group of global leaders to obtain FDA clearance for digital microscopy products.

The FDA 510(k) clearance signifies a significant step for the potential of AI-powered digital microscopy solutions in transforming the healthcare industry.

As per the startup, SigTuple's AI100 with Shonit has the potential to revolutionise the way blood samples are analysed, ultimately improving patient care and diagnostic accuracy while streamlining laboratory processes.

Established in 2015 by Tathagato Rai Dastidar, SigTuple is a medtech startup headquartered in Bengaluru. The startup integrates artificial intelligence, robotics, and data science to develop intelligent screening solutions aimed at enhancing the accuracy, accessibility, and affordability of healthcare.

SigTuple's innovative approach democratises microscopy by enabling AI-assisted remote reviews without the constraints of geographical boundaries.

In a comparable achievement in June, Pune-based startup DeepTek.ai secured a significant milestone with its AI-powered Radiology Workflow Management Solution, Augmento, obtaining India's first 510(k) clearance from the US (FDA) for clinical use.

Likewise, Qure.ai, a Mumbai-based medical imaging AI company, also received FDA clearance for qXR-CTR, its artificial intelligence-enabled chest X-ray solution. The qXR-CTR employs a deep-learning-based computer vision algorithm, purposefully crafted for physicians across inpatient and outpatient settings, to automate the assessment of cardiothoracic ratio (CTR) on chest radiographs (CXR).