Danaher’s (NYSE:DHR) Masimo unit announced today that it received FDA 510(k) clearance for its Patient State Index (PSi) for pediatric patients.
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.
The platform is intended for use by dental professionals, dental service organisations, and imaging centres.
MannKind (Nasdaq:MNKD) announced today that it secured $50 million in a private placement and earned a new regulatory nod.
Momentis Surgical (formerly Memic) announced today that it received FDA 510(k) clearance for the multiport configuration of its surgical robot.
Johnson & Johnson (NYSE:JNJ) announced today that it received FDA de novo authorization for its Ottava surgical robot system.
Philips (NYSE:PHG) today announced that it received FDA 510(k) clearance for its next-generation reusable SpO₂ clip sensor.
Casana announced today that it launched the Smart Seat, a smart toilet seat capable of measuring a range of metrics.
BURLINGTON, Mass., July 20, 2026 /PRNewswire/ — Consano Bio, Inc., a clinical-stage biotechnology company advancing novel therapeutics designed to address serious, painful orthopedic conditions, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for C-1101, its lead investigational therapy for chronic painful lumbosacral radiculopathy (LSR), commonly known as chronic sciatica.
SEOUL, South Korea, July 21, 2026 /PRNewswire/ — Seegene, Inc. (“Seegene”), a global leader in molecular diagnostics, announced today that its U.S. subsidiary, Seegene USA, Inc. (“Seegene USA”), has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Allplex™ HSV-1&2/VZV/MPXV Assay, a multiplex real-time PCR assay designed to simultaneously detect multiple viral pathogens associated with clinically overlapping lesion presentations.