Standards and Guidelines | Tissuepathology.com

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 […]

The post Proscia Achieves SOC 2 Type II Certification, Strengthening Enterprise Trust first appeared on Tissuepathology.com.

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 […]

The post Philips advances minimally invasive therapy procedures in prostate cancer care with FDA 510(k) clearance for image-guided navigation technology first appeared on Tissuepathology.com.

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 […]

The post Indica Labs: Pharma Services Launches GCP-Compliant Image Analysis Service first appeared on Tissuepathology.com.

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 […]

The post Navigating the IVDR: How Aiosyn prioritized compliance from day one first appeared on Tissuepathology.com.

Aiforia secures IVDR certification, paving the way for expanded clinical portfolio in Europe

Erica Goodpaster — Thu, 20 Feb 2025 13:57:52 +0000

Aiforia obtained the In Vitro Diagnostic Regulation (IVDR) certification and successfully launches three new CE-IVD marked AI solutions for breast and prostate cancer diagnostics Aiforia Technologies Plc, Press Release, February 20, 2025 at 10:30 a.m. EET Aiforia Technologies Plc, a provider of cutting-edge AI-assisted medical software solutions, announced today that it has successfully obtained the […]

The post Aiforia secures IVDR certification, paving the way for expanded clinical portfolio in Europe first appeared on Tissuepathology.com.

CAP releases updated guideline for validation of IHC assays

Erica Goodpaster — Wed, 28 Feb 2024 13:03:25 +0000

The College of American Pathologists (CAP) has updated its evidence-based guideline for analytic validation of immunohistochemical (IHC) assays to provide increased accuracy and consistency in laboratory practices. Many of the recommendations published in the original 2014 guideline have remained the same. However, there are new recommendations and modifications in the update developed through assessing evidence […]

The post CAP releases updated guideline for validation of IHC assays first appeared on Tissuepathology.com.