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Leica Biosystems Enables Faster Cancer Diagnoses Through Multiple Digital Pathology FDA Clearances, Including Industry-First AI-Assisted Quality Control Software

Erica Goodpaster — Tue, 11 Aug 2026 12:56:37 +0000

Leica Biosystems: Portfolio expansion marks new era for diagnosis delivery, translating digital pathology innovation to clinical impact by accelerating workflows and patient care VISTA, Calif., August 11, 2026 – Leica Biosystems, a Danaher company and a global leader in end-to-end anatomic and digital pathology solutions, today announced multiple U.S. Food and Drug Administration (FDA) 510(k) clearances […]

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Proscia Receives New FDA 510(k) Clearance for Concentriq AP-Dx with Predetermined Change Control Plan

Erica Goodpaster — Fri, 07 Aug 2026 12:16:20 +0000

PHILADELPHIA — August 6, 2026 — Proscia® has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Concentriq® AP-Dx. The clearance includes compatibility with the Leica Aperio® GT 450 DX slide scanner, cloud deployment, and a Predetermined Change Control Plan (PCCP). Concentriq AP-Dx is a digital pathology platform for primary diagnosis used by laboratories […]

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Proscia Achieves SOC 2 Type II Certification, Strengthening Enterprise Trust

Erica Goodpaster — Thu, 04 Dec 2025 13:51:20 +0000

Compliance with independent security standards comes as Proscia accelerates digital pathology deployments at scale PHILADELPHIA – December 3, 2025 – Proscia®, a pathology AI company, has successfully completed its SOC 2 Type II audit. This milestone underscores the company’s enterprise-grade security and operational rigor, reinforcing its role as the partner of choice for large-scale digital pathology […]

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Philips advances minimally invasive therapy procedures in prostate cancer care with FDA 510(k) clearance for image-guided navigation technology

Erica Goodpaster — Fri, 25 Jul 2025 12:19:42 +0000

Philips: Supporting prostate cancer diagnosis with more precise guidance for clinicians, offering better patient care Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced a major advancement in image-guided navigation for prostate cancer care with the FDA 510(k) clearance of the latest Philips UroNav version. The system includes a […]

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Indica Labs: Pharma Services Launches GCP-Compliant Image Analysis Service

Erica Goodpaster — Wed, 09 Jul 2025 11:48:58 +0000

Albuquerque, NM, July 8, 2025 – Indica Labs, the global leader in AI-powered digital pathology software and services, today announces that their Pharma Services team is offering quantitative image analysis studies designed and performed to Good Clinical Practice (GCP) standards. With GCP image analysis services, customers can rest assured that the quantitative image analysis data in their translational and […]

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Navigating the IVDR: How Aiosyn prioritized compliance from day one

Erica Goodpaster — Wed, 28 May 2025 11:22:02 +0000

From the Aiosyn Blog IVDR represents a significant overhaul of regulations requiring more rigorous oversight, clinical validation assessed by a Notified Body, and stricter post-market surveillance (PMS). Aiosyn’s AI-powered solution for mitotic figure counting was built from the ground up to comply with IVDR’s highest regulatory standards rather than transitioning from the superseded IVDD. Aiosyn […]

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