FDA Approval | Tissuepathology.com

Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer

Erica Goodpaster — Wed, 17 Jun 2026 11:42:11 +0000

Roche: The new VENTANA® PTEN (SP218) RxDx Assay fulfills an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with TRUQAP. In prostate cancer, PTEN protein loss is associated with faster disease progression and reduced benefit from current standard-of-care treatments.1 The FDA approval reinforces Roche’s leadership […]

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FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer

Erica Goodpaster — Wed, 18 Feb 2026 12:46:24 +0000

FDA: Device Delivers Non-invasive Therapy and Supports Care at Home White Oak, Md., Feb. 12, 2026 (GLOBE NEWSWIRE) — The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical […]

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PathAI Receives FDA Clearance for AISight® Dx Platform for Primary Diagnosis

Erica Goodpaster — Wed, 02 Jul 2025 11:53:21 +0000

Boston – June 30, 2025 – PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight® Dx*—its digital pathology image management system—for use in primary diagnosis in clinical settings. Building on the initial 510(k) clearance for AISight Dx(Novo) […]

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It’s Time to Re-Read Player Piano

Dr. Keith J. Kaplan — Thu, 22 May 2025 14:20:00 +0000

“The main business of humanity is to do a good job of being human beings,” said Paul, “not to serve as appendages to machines, institutions, and systems.” If you have not read Player Piano, it is a good read. I read it many years ago along with many other Vonnegut novels and listed to Player […]

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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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Roche’s momentum in digital pathology continues with FDA clearance on its high-volume slide scanner

Erica Goodpaster — Thu, 09 Jan 2025 14:39:52 +0000

The VENTANA DP 600 slide scanner, part of Roche’s Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the […]

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