Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

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) in 2022, this latest milestone underscores the platform’s continuous innovation and PathAI’s commitment to delivering enhanced capabilities as the product evolves.

Microsoft has built an artificial intelligence-powered medical tool it claims is four times more successful than human doctors at diagnosing complex ailments, as the tech giant unveils research it believes could speed up treatment.

Paige, a leader in next-generation AI technology, and the Breast International Group (BIG), a leading international non-profit organization dedicated to breast cancer research, today announced a new partnership to conduct collaborative research aimed at improving breast cancer diagnosis, treatment, and patient outcomes.

PathAI, a leading provider of AI-powered pathology solutions, and Northwestern Medicine, Chicago’s premier integrated academic health system, today announced a strategic collaboration to transform pathology diagnostics through artificial intelligence. This multi-year collaboration will see Northwestern Medicine implement PathAI’s AISight digital pathology image management system with the goal of driving efficiency and quality in pathology operations. In addition to the digital innovation efforts, this joint effort establishes a broad framework for joint research initiatives, clinical innovation programs, and co-development of new AI-powered diagnostic tools aimed at improving patient outcomes.

Illumina Inc. (NASDAQ: ILMN) today unveiled PromoterAI, a new AI algorithm that accurately deciphers pathogenic regulatory genetic variants in the noncoding regions of the human genome. A study published today in Science illustrates how this deep learning technology discovered regulatory variants in noncoding "promoter" segments that contribute up to 6% of the genetic causes of rare diseases. By turning data into insights, this technology is expected to help researchers accelerate new breakthroughs in diagnosis for rare diseases.

Biostate AI said Tuesday that it has raised $12 million in a Series A financing round.

Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced a collaboration to develop a companion diagnostic (CDx) test with Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers. Tempus completed confirmatory testing in Verastem’s Phase 2 RAMP-201 clinical trial, which evaluated the combination of avutometinib and defactinib to treat recurrent low-grade serous ovarian cancer (LGSOC) and was the basis of the recent U.S. Food and Drug Administration’s (FDA) accelerated approval of the combination in KRAS-mutated recurrent LGSOC.

Currently, most level-Ⅲ hospitals and some level-Ⅱ hospitals in China are equipped with automated and intelligent diagnostic devices.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has signed a definitive agreement to acquire Genoox, a provider of AI-powered software that enables clinical labs to scale and accelerate the processing of complex genetic tests.