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.
NAPLES, Fla., July 16, 2025 /PRNewswire/ — Arthrex, a global leader in minimally invasive surgical technology, announced that it has received U.S. Food and Drug Administration (FDA) clearance to use the Arthrex NanoScope™ operative arthroscopy system for pediatric orthopedics and laparoscopy.
CVRx (Nasdaq:CVRX) announced today that CMS proposed to keep its Barostim implant procedure within a certain payment class.
Non-Invasive Histotripsy Treatment Now Accessible to 7 Million Blue Cross Blue Shield Highmark Members Across U.S.
The CE Mark approval of the VitalFlow™ ECMO System marks a significant advancement in extracorporeal life support, delivering enhanced precision and control for managing critically ill cardiac and respiratory patients.