USFDA approval granted for Blood Smear Application

This USFDA approval marks a significant stride, as it is the first integrated hardware and AI medical device to receive clearance.

The Health Master

September 27, 2023

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Last Updated on December 22, 2024 by The Health Master

USFDA approval

In a groundbreaking development, SigTuple, a pioneering medtech company specializing in AI-powered digital microscopy solutions, has achieved a significant milestone in the form of USFDA approval.

The U.S. Food and Drug Administration (USFDA) has granted 510(k) clearance for their cutting-edge device, the AI100 with Shonit—a peripheral blood smear application.

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Transforming Clinical Laboratories

SigTuple’s Chief Product Officer, Apurv Manjrekar, highlighted the pivotal role their product plays in automating a critical manual process within clinical laboratories.

He emphasized that the device tackles the microscopic review of blood samples, a vital step in detecting a wide array of diseases.

This USFDA approval marks a significant stride, as it is the first integrated hardware and AI medical device to receive clearance.

Notably, it also stands as the inaugural product in AI-assisted digital microscopy originating from India.

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The Significance of Peripheral Blood Smear Examination

The examination of peripheral blood smears (PBS) serves as the gold standard test for diagnosing various hematological disorders, encompassing conditions like blood cancer, infections, anemia, and allergies.

However, presently, this microscopic examination primarily relies on manual intervention, necessitating the presence of a highly skilled pathologist on-site.

The Ingenious Solution: AI-Assisted Digital Pathology

The AI100 with Shonit emerges as a trailblazing solution in the realm of AI-assisted digital pathology.

It employs a process where a physical sample undergoes digital imaging through a microscopic lens.

Subsequently, AI models take charge, meticulously extracting and categorizing each cell into over 30 distinct cell types.

Empowering Pathologists, Revolutionizing Diagnoses

This innovative device enables pathologists to review samples remotely, transcending the limitations of traditional microscopy.

Moreover, the integration of AI augments the pathologist’s efficiency by automating a significant portion of the review process.

Consequently, the same pathologist can now handle a considerably larger volume of samples, obviating the need for additional manual reviews.

A Gateway to International Expansion

The founder and CEO of SigTuple, Tathagato Rai Dastidar, expressed profound optimism about the clearance’s implications.

He anticipates that this milestone will unlock multiple avenues for international expansion, propelling SigTuple towards the forefront of global medical technology companies beyond the borders of India.

Insights into the USFDA Drug Approval Process:

1. Regulatory Affairs Consulting:

Essential for navigating the complex landscape of USFDA approvals.
Ensures adherence to stringent regulatory guidelines.

2. USFDA Drug Approval Process:

A meticulous process involving rigorous evaluation of safety and efficacy.
Demands comprehensive documentation and compliance with USFDA standards.

3. Generic Drug Approval Pathway:

An economical alternative to brand-name drugs, requiring a robust Abbreviated New Drug Application (ANDA).
Necessitates a thorough demonstration of bioequivalence.

4. USFDA Expedited Programs:

Designed to accelerate the approval process for drugs addressing unmet medical needs.
Includes Fast Track Designation, Breakthrough Therapy Designation, Priority Review Process, and Accelerated Approval Process.

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