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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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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was built from the ground up to comply with IVDR’s highest regulatory standards rather than transitioning from the superseded IVDD.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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CORRECTING and REPLACING: Tribun Health Achieves FDA Clearance for CaloPix Digital Pathology Platform With Dual Scanner Compatibility

Erica Goodpaster — Thu, 22 May 2025 12:08:42 +0000

[CORRECTED RELEASE] Updated to clarify reference to dual-scanner FDA clearance. PARIS, FRANCE / ACCESS Newswire / May 21, 2025 / Tribun Health, a leader in digital pathology, proudly announces that its flagship web-based image management system, CaloPix®, has received FDA 510(k) clearance for use with two leading whole slide imaging scanners: the Hamamatsu NanoZoomer S360MD and the Leica […]

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U.S. FDA Grants Paige Breakthrough Device Designation for AI Application that Detects Cancer Across Different Anatomic Sites

Erica Goodpaster — Mon, 07 Apr 2025 13:06:58 +0000

Paige PanCancer Detect recognized by FDA as a Breakthrough Device intended to assist pathologists in the detection of cancer across multiple tissue and organ types NEW YORK–(BUSINESS WIRE)–Paige, a leader in next-generation AI technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Paige PanCancer Detect*, an AI-assisted diagnostic […]

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