Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the FDA has approved the VENTANA® MET (SP44) RxDx Assay, the first companion diagnostic approved to aid in determining MET (also known as c-Met) protein expression in NSQ-NSCLC patients. These patients may now be eligible for treatment with AbbVie’s c-Met-targeted therapy Emrelis™ (telisotuzumab vedotin-tllv).

Teal Health®, a women’s health company on a mission to eliminate cervical cancer, today announced the Food and Drug Administration’s (FDA) approval of the Teal Wand™, the first and only at-home vaginal sample self-collection device for cervical cancer screening in the United States.

The US Food and Drug Administration (FDA) has set an “aggressive” timeline to implement generative artificial intelligence (genAI) across the agency by 30 June 2025.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the VENTANA® TROP2 (EPR20043) RxDx Device. This is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic (CDx) device.

Diasorin (FTSE MIB: DIA) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the second1 of its 3 multiplex molecular panels for blood culture pathogen identification on the LIAISON PLEX® system.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for BD Phoenix™ M50 and BDXpert™ System on the BD Synapsys™ Informatics Solution, leveraging rapid identification (ID) and antimicrobial susceptibility testing (AST) algorithms to assist in the interpretation of complex diagnostic data to help ensure accurate and reliable diagnoses related to antimicrobial resistance (AMR).

More than 200 biotech leaders have penned a letter voicing concerns over the FDA’s capacity after mass federal layoffs, specifically for small biotechs that depend on investor backing to meet agency standards.

Siemens Healthineers said Friday that it has received US Food and Drug Administration 510(k) marketing clearance for the use of its antithrombin activity assay as a companion diagnostic for Sanofi's Qfitlia (fitusiran), which was approved as a routine prophylaxis to prevent bleeding episodes in hemophilia patients.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, further strengthening its syndromic testing portfolio in the United States.

Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use.