
Takeda Secures FDA 510(k) Clearance for HyHub™ and HyHub™ Duo Devices
New devices designed to streamline and personalize HYQVIA® administration for patients receiving subcutaneous immune globulin therapy

New devices designed to streamline and personalize HYQVIA® administration for patients receiving subcutaneous immune globulin therapy

AUSTIN, Texas, July 21, 2025 /PRNewswire/ — Electrophysiologists at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center recently became the first in the nation to implant an FDA-approved novel leadless system that provides cardiac resynchronization therapy to patients with heart failure. Cardiac resynchronization therapy improves the timing of the heart’s contractions, helping to restore the normal rhythm of the heartbeat. The first procedure was recently performed by Robert Canby, M.D., cardiac electrophysiologist at TCAI.

Spirair announced today that the FDA granted 510(k) clearance for its TurbAlign bioabsorbable implant device.

Boston Scientific (NYSE: BSX)+
has received expanded FDA approval for the use of its Watchman FLX and Watchman FLX Pro devices.

NDA for TAR-200 targets high-risk non-muscle invasive bladder cancer, highlighting potential to transform treatment for patients unresponsive to BCG therapy

UroMems announced that it received FDA investigational device exemption (IDE) approval to begin a first-of-its-kind trial for its smart implant.

MINNEAPOLIS, July 17, 2025 /PRNewswire/ — Saluda Medical, Inc., a pioneer in the development and commercialization of a novel neuromodulation platform designed to transform the lives of patients with chronic neurological conditions, today announced the full commercial launch of EVA, its next-generation sensing technology, in the United States (U.S.). EVA received U.S. Food & Drug Administration (FDA) approval in December 2024 and is compatible with all commercially implanted Evoke® SmartLoop™ System patients.

The FDA approval of Thermo Fisher’s Oncomine Dx Express Test marks a key advancement in precision oncology, enabling fast, accurate detection of EGFR exon 20 insertion mutations and guiding NSCLC patients to targeted treatments like ZEGFROVY.

SAN FRANCISCO, July 16, 2025 /PRNewswire/ — Piccolo Medical, Inc. (Piccolo), a leading innovator in vascular access technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its next-generation SmartPICC® Stylet and PM2+™ System. This significant achievement marks a major leap forward in safe, efficient, and cost-effective peripherally inserted central catheter (PICC) placement, offering enhanced benefits for both patients and healthcare providers.

CHARLOTTESVILLE, Va., July 16, 2025 /PRNewswire/ — RIVANNA®, developers of world-first imaging-based medical technologies, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) regarding the Accuro® 3S diagnostic ultrasound system and SpineNav-AI™ image processing software. This clearance authorizes the use of both technologies in United States hospital and clinical settings, providing anatomical guidance during needle or catheter placement.