Histoindex Pte Ltd. launched its laboratory-developed test for metabolic dysfunction-associated steatohepatitis (MASH), Fibrosight, in the U.S. as the company’s first in a suite of next-generation digital pathology solutions.
Paige AI Inc.’s partnership with Microsoft Corp., announced last September, appears to have paid off quickly, with a study published in Nature Medicine demonstrating that their jointly developed image-based artificial intelligence model, Virchow, detects 16 cancer types as well or better than tissue-specific clinical-grade models.
The U.S. FDA cleared Basel, Switzerland-based Roche Holding AG’s whole-slide imaging system, the Roche Digital Pathology Dx, for use as an aid in clinical diagnosis. The system helps pathologists review and interpret digital images of scanned pathology slides.
Fujifilm Corp. inked an agreement to purchase the global digital pathology business of Inspirata Inc., paving the way for expansion of its Synapse enterprise imaging offering. The transaction includes Inspirata’s Dynamyx software, which Fujifilm has distributed in the U.K. and certain European Union countries since mid-2020. Under the agreement, Fujifilm will acquire Inspirata’s digital pathology technology, as well as employees and customers associated with the brand. Financial terms of the deal were not disclosed. It is expected to close in early 2023.
Genomics is moving out of the research lab to become a routine element of health care, particularly in oncology to detect gene variants that indicate a patient will respond to a targeted cancer drug, and in the diagnosis of rare diseases.
Owkin Inc. has secured CE marking for two first-in-class artificial intelligence (AI)-based diagnostics, marking a move from research use only and towards the mainstream for AI in enabling faster and more efficient analysis of digital pathology slides.
Ibex Medical Analytics Ltd. extended the reach of its artificial intelligence (AI) powered pathology system, adding gastric cancer to existing CE mark approvals in prostate and breast cancer.
Stratipath AB gained CE-IVD mark for its artificial intelligence (AI)-based software for prognostic risk stratification of breast cancers, clearing the path for introduction of the solution in the EU. Stratipath Breast analyzes digital histopathology whole slide images generated from surgically resected breast cancer tissue to identify patients with increased risk of disease progression. The system provides clearer guidance on the best treatment path for the 50% of women whose breast cancer is categorized as intermediate risk.
Roche Diagnostics International Ltd. is joining forces with Bristol Myers Squibb Co. (BMS) to develop two new digital pathology algorithms to support cancer assay use in clinical trials. Roche Digital Pathology will create an artificial intelligence (AI) based image analysis algorithm to assist pathologists in interpreting the company’s FDA-approved Ventana D-L1 (SP142) assay for urothelial carcinoma patients. BMS will use the algorithm to generate biomarker data from clinical trial samples.
LONDON – Ibex Medical Analytics Ltd. has secured a second CE marking for its Galen artificial intelligence decision support system for automated interpretation of tumor biopsies, adding breast cancer to the approval in prostate cancer secured just over a year ago. The CE mark follows results from a blinded, multicenter clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Ibex says that in the trial Galen breast demonstrated very high accuracy in detecting various types of breast cancer.