MedTech News:

FEMTECH

Roche receives FDA clearance for the cobas® BV/CV assay, enabling fast and highly accurate vaginitis diagnosis

INDIANAPOLIS, July 24, 2026 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cobas® BV/CV (Bacterial vaginosis/Candida vaginitis) assay. This molecular diagnostic test provides results for both Bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab sample. It enables accurate and timely results that can lead to improved patient outcomes and enhanced healthcare efficiencies.

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Quibim launches CE and UKCA-marked QP-Breast

Quibim has announced the European and UK launch of QP-Breast, its CE and UKCA-marked AI tool – the first in Europe and the United Kingdom to detect breast cancer using magnetic resonance imaging – which automatically identifies suspected lesions on breast MRI.

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