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HomeHealthHologic AI-powered cancer screening system wins FDA approval

Hologic AI-powered cancer screening system wins FDA approval

Medical technology company Hologic has obtained FDA clearance to market its Genius digital diagnostic system, powered by the company’s Genius Cervical AI algorithm.

The digital cytology system, a medical diagnostic tool used to examine cells under a microscope to detect abnormalities or diseases, integrates deep learning-based AI with advanced volumetric imaging technology to help detect precancerous lesions and cervical cancer cells.

Its commercial launch is expected at the end of this year. Its technology is now available in Europe, Australia and New Zealand.

Cervical cancer screening typically involves a Pap smear, in which samples of cells from the cervix are collected in an OB/GYN office and sent to a laboratory for analysis on glass slides.

By digitizing glass slides for analysis through the AI ​​algorithm, the company says the system can improve sensitivity without compromising specificity and facilitate more timely and effective treatment decisions.

The company claims the system reduces false negatives by 28% for high-grade squamous intraepithelial lesions and more severe lesions compared to traditional microscopic review.

Hologic also touted that the system benefits healthcare professionals by enabling remote case review and leveraging the expertise of geographically dispersed experts.

The system is scalable to meet the changing needs of the laboratory and includes a digital imager for image acquisition, the Genius Cervical AI algorithm for analysis, an image management server for storage, and Genius Review Station for case review.


Recent data from the American Cancer Society predicts that there will be 13,820 new cases of invasive cervical cancer and approximately 4,360 related deaths in the US in 2024, and effective prevention and treatment critically depend on early detection of the disease.

The integration of artificial intelligence and machine learning technologies into healthcare applications and devices continues to offer promising benefits for everything from diabetes management to predict the accumulation of amyloid beta protein, the main biomarker of Alzheimer’s.

Absci and pharmaceutical giant AstraZeneca are also leveraging AI to boost research into Candidates for anticancer drugs.

As funding for AI-powered healthcare solutions gains momentum in 2024, regulators (and the industry) are debating how to design regulations and rules that guide the use of technology in healthcare.

During the HIMSS AI in Healthcare Forum held in San Diego in December 2023, a panel of experts outlined Practical strategies for adopting and investing in AI.

Panelists discussed methodologies to optimize the effectiveness of AI initiatives and deliberated on the critical considerations involved when choosing between adopting pre-existing AI solutions or developing new AI infrastructure.



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