Hologic Gets FDA Clearance For Cancer-Cell Diagnostic System

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By Ben Glickman

Hologic said Thursday it had received clearance from regulators for its cancer-cell detecting digital diagnostic system.

The Marlborough, Mass.-based medical technology company said it expects its Genius Digital Diagnostics System to become available in early 2024.

According to Hologic, its system uses artificial intelligence and imaging technology to help locate pre-cancerous lesions and cervical cancer cells.

The company said it was the first FDA-cleared digital cytology system.

The system can read glass slides from pap test used to screen for cervical cancer. The Genius system identifies cells that experts should review.

Hologic’s system is already available in Europe, Australia and New Zealand.


Write to Ben Glickman at [email protected]

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