Flash Pathology is proud to announce that it has officially achieved ISO 13485 certification, marking an important milestone as the year comes to a close. This certification demonstrates Flash Pathology’s commitment to meeting the highest international standards for the development of medical devices and reflects its ongoing dedication to quality, safety, and reliability for partners and [...]
Artificial intelligence is rapidly transforming clinical medicine, with AI-powered tools increasingly being used for diagnostic imaging interpretation, clinical decision support, predictive analytics and treatment planning. As healthcare organizations adopt AI technologies and developers bring new products to market, they face an evolving regulatory landscape involving ongoing legislative debate, Food and Drug Administration (FDA) oversight, changes in [...]
Author: Sidney Ocanagil-Tunstall December 15, 2025 The U.S. Food and Drug Administration (FDA) has today U-turned on a major limitation regarding the use of real-world evidence (RWE) in drug and medical device application reviews. In new guidance for certain types of medical device submissions, the agency states that “it will accept RWE without requiring [...]
Indica Labs’ new spatial analysis application note provides a detailed look at the tools provided by the HALO Spatial Analysis module for identifying proximity and relative spatial distribution of cells and objects. The module offers four algorithms, nearest neighbor, proximity, infiltration, and density heatmap, and this paper discusses and demonstrates how each can be used in quantitative [...]
PathAI is thrilled to announce the release of AISight Dx v2.18, packed with new capabilities that strengthen operational visibility, streamline daily workflows, and give teams more control over collaboration and access. This release brings Operational Dashboards, smarter self-service tools, and faster, more consistent reporting . Guided by customer feedback, PathAI will continue to evolve AISight Dx [...]
by Christos Evangelou, MSc, PhD – Medical Writer and Editor Traditional bulk sequencing methods provide a broad overview of tumor tissues but miss crucial details about cellular context and interactions. In contrast, spatial biology technologies can help uncover tumor heterogeneity by mapping molecular information directly onto tissue architecture. Sweden’s new Precision Omics Initiative, termed PROMISE, [...]
ZayaAI is embedding Lumea’s viewer into the Zaya LIS, creating a single digital workspace for pathologists. This streamlines workflows and boosts efficiency. Lumea, the U.S. leader in primary clinical digital pathology, and ZayaAI, a next-generation pathology LIS provider, have announced a strategic collaboration to deliver a single, connected digital workspace for real-world diagnostics. By embedding Lumea’s [...]
This article summarizes part 1 of “Into the Pathoverse” webinar, recorded at Pathology Visions 2025 in San Diego and available on-demand. Watch the full video. Every major innovation begins with a spark—a problem so persistent and universal that someone finally decides to solve it. For PathPresenter, that spark came from a challenge faced by pathologists [...]
By Ben Dyer As scientists work to continue unraveling the structural, cellular, and molecular complexities of the brain and its diseases, the characteristics of this unique tissue pose significant challenges to traditional histological analysis. Further complicating the issue, neuroscience studies increasingly leverage large datasets, multiplexed imaging, and multimodal quantification, producing large volumes [...]
Cloud technology introduces unprecedented flexibility, scalability, and collaboration1. By moving pathology data to the cloud, pathologists can access cases from anywhere, collaborate across institutions and leverage AI tools without infrastructure constraints. The cloud eliminates the limitations of on-premises systems. For healthcare organizations, this means the possibility to improve operational efficiency, reduced IT overhead and the ability [...]
