FDA grants clearance for Hologic’s cancer screening system

The US Meals and Drug Administration (FDA) has granted clearance for Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm for cervical most cancers screening.

This technique is claimed to be the primary FDA-cleared digital cytology platform that integrates deep-learning-driven synthetic intelligence (AI) with volumetric imaging know-how.

The event marks a major development within the detection of pre-cancerous lesions and cervical most cancers cells.

The Genius Digital Diagnostics System revolutionises the normal Pap take a look at course of by digitising the glass slides and making use of an AI algorithm.

This methodology has proven a notable discount in false negatives for high-grade lesions, with a 28% enchancment in comparison with normal microscopic evaluation.

Its capacity to reinforce sensitivity with out compromising specificity is an important improvement in affected person care, offering extra dependable and well timed remedy choices.

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Providing a scalable answer for laboratories, the system’s parts embody the Genius Digital Imager, Picture Administration Server, Cervical AI algorithm, and Overview Station.

This flexibility ensures that the system can meet each present and future calls for.

The Genius Digital Diagnostics System additionally facilitates better collaboration by permitting safe distant case critiques, leveraging the experience of specialists no matter their location.

Already accessible in Europe, Australia, and New Zealand, the brand new system is anticipated to be commercially accessible within the US in early 2024.

Hologic Diagnostic Options President Jennifer Schneiders stated: “Hologic is a number one innovator in girls’s well being with a dedication to advancing cervical and breast most cancers screening applied sciences, from the primary liquid-based cytology take a look at to the primary 3D mammography system and now the primary FDA-cleared digital cytology platform.

“Our applied sciences have had an incredible affect on reducing most cancers charges in girls, and we’re extremely excited by the promise of Genius Digital Diagnostics. The system delivers extra actionable and correct insights for laboratories and healthcare professionals to reinforce affected person care.”

Final 12 months, the corporate secured 510(okay) clearance from the US FDA for its absolutely automated and high-throughput Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.


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