From January 2024 and June 2025, the U.S. Food and Drug Administration (FDA) approved 39 in-vitro toxicology testing products through the 510(k). This period marked a significant reshaping of the global market: Chinese companies, driven by rapid product iteration and precise market positioning, surged in the market share. At the same time, the worsening fentanyl crisis in the U.S. fueled an unprecedented demand for fentanyl testing, making it the most competitive and dynamic segment in the field.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic (IVD) test cleared by the U.S. Food and Drug Administration (FDA) to aid in the diagnosis of Alzheimer's disease through early detection of the amyloid plaques associated with the disease in appropriate patients. Developed by Fujirebio Diagnostics, Inc., the test is now available nationwide through Labcorp.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the addition of Anterior Nasal Swab (ANS) as a validated specimen type for this panel, specifically for use with the respiratory test menu. By swabbing only the anterior part of the nasal cavity, ANS provides significantly more comfort for the patient.

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

Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for ArteraAI Prostate, establishing it as the first and only AI-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer.

Research and development of new AI-powered tech is causing a major overhaul in the healthcare sector, with experts both optimistic and horrified at the same time. Analysts at market.us are forecasting the global AI in healthcare market to hit nearly $700 billion by 2034, growing at an explosive 38.5% CAGR along the way. With new technologies getting closer to full FDA approval, now one of the biggest hurdles for AI in healthcare is gaining the trust of clinicians and patients alike, all while proving efficacy of these new solutions. From an investment standpoint, the opportunity is enormous, with the market paying closer attention to AI roll outs and the developers behind them, including Avant Technologies, Inc. (OTCQB: AVAI), RadNet, Inc. (NASDAQ: RDNT), Clover Health Investments, Corp. (NASDAQ: CLOV), Tevogen Bio Holdings Inc. (NASDAQ: TVGN), and Butterfly Network, Inc. (NYSE: BFLY).

Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients who may be candidates for HERNEXEOS® (zongertinib tablets), a tyrosine kinase inhibitor (TKI), developed by Boehringer Ingelheim. The test allows clinicians and pathologists to assess if non-small cell lung cancer (NSCLC) tumors harbor human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations.

Roche on Monday announced that its Cobas Respiratory 4-flex test for SARS-CoV-2, influenza A/B, and respiratory syncytial virus has received clearance from the US Food and Drug Administration.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test designed to detect COVID-19 antigens in symptomatic individuals in about 15 minutes at doctors' offices, urgent care centers, retail clinics and other convenient points of care.

Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, received FDA approval to streamline the stool collection process for ColoSense®, its RNA-based colorectal cancer (CRC) screening test. The newly approved collection kit no longer requires patients to separate their sample into multiple containers. This improves ease of use and reduces barriers to at-home screening,¹ while maintaining clinical performance.