HALO AP Dx

Indica Labs, HALO AP Dx, FDA 510(k)-cleared digital pathology platform displayed with the Aperio GT 450 DX Scanner for in vitro diagnostic use.

Indica Labs Receives FDA Clearance for Enterprise Digital Pathology Platform with Industry Leading DICOM-Compatible Aperio Scanner from Leica Biosystems

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ALBUQUERQUE, NM, and VISTA, CA, December 3, 2025 – Indica Labs, the global leader of AI-powered digital pathology, and Leica Biosystems, a global leader in anatomic and digital pathology solutions, announced today that the Food and Drug Administration (FDA) has issued a 510(k) clearance for the enterprise digital pathology platform HALO AP Dx in conjunction with Leica Biosystems Aperio GT 450 DX Scanner for in-vitro diagnostic use.

Indica Labs Receives FDA Clearance for Enterprise Digital Pathology Platform with Industry Leading DICOM-Compatible Aperio Scanner from Leica Biosystems Read More »

Indica Labs Receives FDA Clearance for HALO AP Dx Digital Pathology Platform for Use with Hamamatsu Images Acquired with the NanoZoomer® S360MD Slide Scanner

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Albuquerque, NM, and Hamamatsu City, Japan – 22 May, 2024 – Indica Labs, an industry leader in AI-powered digital pathology solutions, and Hamamatsu Photonics K.K., a pioneer in whole slide imaging systems, announce that the U.S. Food and Drug Administration (FDA) has issued a 510(k) clearance to Indica Labs for HALO AP Dx, an enterprise digital pathology platform.

Indica Labs Receives FDA Clearance for HALO AP Dx Digital Pathology Platform for Use with Hamamatsu Images Acquired with the NanoZoomer® S360MD Slide Scanner Read More »

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