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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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Spotlight Medical Secures IVDR CE Marking for myStage Dx, Its AI-Enabled Prognostic Test for ER+/HER2 – Early Breast Cancer

Erica Goodpaster — Tue, 23 Jun 2026 13:17:57 +0000

Spotlight Medical: Class C software-only IVD supports European rollout of a JCO-published assay designed to bring clinically validated prognostic assessment into routine breast cancer care. PARIS–(BUSINESS WIRE)–Spotlight Medical, a Paris-based oncology diagnostics company, today announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) […]

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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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Diagnexia Achieves Full UKAS Accreditation for Oxford Histopathology Laboratory and Digital Pathology Services

Erica Goodpaster — Thu, 06 Nov 2025 13:50:26 +0000

From Backlogs to Rapid Diagnosis: Diagnexia Secures Full UKAS Accreditation for End-to-End Histopathology OXFORD, UK – 04/11/2025 – Responding to increasing demand for reliable pathology reporting across the NHS, Diagnexia UK Limited has achieved UKAS accreditation* to ISO 15189:2022 for its Histology laboratory, Oxford, enabling trusts to access a fully accredited end-to-end histopathology service from specimen […]

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Artera Achieves Nationwide Access for its ArteraAI Prostate Test with New York State License

Erica Goodpaster — Fri, 13 Jun 2025 10:54:24 +0000

Artera: Clinicians and patients throughout New York State can now access personalized, actionable insights to inform prostate cancer treatment decisions SAN FRANCISCO–(BUSINESS WIRE)–Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today it has received its New York laboratory permit from its Department of Health. This licensure allows Artera to […]

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