The US Food and Drug Administration on Tuesday issued a letter to medical device manufacturers and sponsors of device studies warning them to independently verify performance test results before submitting them to the agency due to concerns about fraudulent results.

If Chinese chemiluminescence would eventually replace imported products completely, it must ensure the accuracy and reliability of the test results. In addition to the improvement of equipment system and methodology, the accuracy of results will involve two very core competitions in the future.

Freenome said on Thursday that it raised $254 million in funding from existing and new investors to advance its pipeline of single- and multi-cancer early detection tests.

Werfen has received CE marking for its Aptiva antiphospholipid syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents, meaning the in vitro diagnostics can now be used in the EU.

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostics products, today announced financial results for the fourth quarter and full year ended December 31, 2023.

QuidelOrtho Corporation (Nasdaq: QDEL) (the “Company” or “QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, today announced financial results for the fourth quarter and full-year ended December 31, 2023.

The analyzer will develop in two directions as per different customer needs and application scenarios.

SCIEX, a global leader in life science analytical technologies, launches the Echo® MS+ system at SLAS 2024. The system couples proprietary Acoustic Ejection Mass Spectrometry technology and Open Port Interface (OPI) sampling with the capabilities of either the SCIEX ZenoTOF 7600 or Triple Quad 6500+ system to deliver precise qualitative and quantitative results, through an expanded panel of robust high-throughput screening workflows.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced results for its first quarter of fiscal 2024, which ended December 31, 2023.

The US Food and Drug Administration said on Wednesday that its Center for Devices and Radiological Health (CDRH) is planning a process to reclassify some high-risk in vitro diagnostics as moderate risk in a move that the agency said would allow manufacturers to seek marketing clearance for their tests through a less stringent regulatory pathway.

Revvity, Inc. (NYSE: RVTY), today reported financial results for the fourth quarter and full year ended December 31, 2023.

Siemens Healthineers AG today announces its results for the first quarter of fiscal year 2024 ended December 31, 2023.

Group sales grow by 1% at constant exchange rates (CER; -7% in CHF), more than offsetting the decline in COVID-19-related sales and biosimilar erosion, and thereby exceeding 2023 guidance

From 2019 to 2022, the market experienced substantial growth, surging from $124.7 million to $1,155.6 million at an impressive Compound Annual Growth Rate (CAGR) of 110.1%. Projections indicate a continued expansion, reaching an estimated $75,568.8 million by 2030, albeit with a moderated CAGR of 39.2%, signaling a deceleration in market growth.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Techcyte, a world leader in artificial intelligence (AI)-based digital diagnostics, today announced a strategic collaboration agreement to offer an AI-based algorithm that guides cytologists and pathologists to efficiently and effectively identify evidence of cervical cancer and precancer using whole-slide imaging.