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Tribun Health Announces CaloPix(R) 6, Its First IVDR-Certified Version for Routine Diagnostic Use

Regulation & LegislationHealthcare & BiotechTechnology & Innovation

The company reported an FDA clearance in 2025 followed by CaloPix’s IVDR certification, which it says enables Tribun Health to serve the global digital pathology market. The update signals regulatory traction for its digital pathology offering, supporting broader commercial deployment internationally.

Analysis

The company reported an FDA clearance in 2025 followed by CaloPix’s IVDR certification, which it says enables Tribun Health to serve the global digital pathology market. The update signals regulatory traction for its digital pathology offering, supporting broader commercial deployment internationally.

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