Danaher reported on Tuesday that its second quarter revenues fell approximately 8 percent year over year due to ongoing declines in COVID-related product demand and a drop in biotechnology business revenues.

On July 10, 2023, NMPA released information on the delivery of medical device approval certification documents.

LumiraDx Limited (Nasdaq: LMDX), a leading innovator in diagnostic technologies, today announced the submission of its first 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its ground-breaking 5-minute COVID Ultra Test. LumiraDx submitted a traditional 510(k) Dual Submission for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the commercial distribution at point of care of the LumiraDx Platform, including the LumiraDx Instrument, with the LumiraDx SARS-CoV-2 Antigen (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit.

Looking at the overall environment, the receding of the COVID-19 testing dividend, the slowdown of conventional business growth, and the pressure from the collection policy have all brought the IVD industry into an adjustment period.

Cue Health, a healthcare technology company, announces an industry breakthrough as the first company to receive De Novo authorization from the U.S. Food and Drug Administration (FDA) for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use.

Hologic Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay. This assay is a molecular diagnostic test that detects and differentiates four of the most prevalent respiratory viruses that can exhibit similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (flu A), influenza B (flu B) and respiratory syncytial virus (RSV).

The first diagnostic test for long COVID is now available to patients across Australia. The test can help physicians diagnose long COVID by differentiating it from other diseases with similar symptoms, and to design personalized treatment approaches.

LumiraDx on Tuesday reported an 82 percent year-over-year decrease in first quarter revenues due to falling demand for COVID-19 testing.

DiaSorin said that its first quarter 2023 revenues fell 19 percent year over year on a sharp decline in COVID-19 testing, partially offset by growth in its non-COVID-19-related diagnostics revenues.

From March 15, China has officially announced the resumption of all kinds of visas, including tourist visas (L Visa), and visa-free policies have been reinstated.