Elucent Medical announced today that it received FDA breakthrough device designation for its EnVisio X1 In-Body Spatial Intelligence system.
First-of-its-kind platform offers real-time fetal heart documentation and congenital heart disease detection, revolutionizing prenatal care and diagnosis.
Go-Pen ApS announced recently that it received FDA 510(k) clearance for its Go-Pen cost-effective, user-filled insulin pen.
A subsidiary of Tandem Diabetes Care (Nasdaq:TNDM) recently picked up FDA clearance for infusion technology to support insulin delivery
High-Precision Type 5 Indicator Enhances Patient Safety by Validating Steam Sterilization Cycles in Clinical Settings
HOUSTON, May 12, 2025 /PRNewswire/ — United Imaging, a global manufacturer of modern medical imaging technology, announces that its first Interventional X-ray system is now FDA cleared. uAngio AVIVA is an intuitively bionic ceiling-mounted system that uses intelligent robotics, voice control, vision and imaging to serve as a critically important assistant to clinical staff in the interventional suite.
Zynex (Nasdaq:NYXI) announced today that it submitted its NiCO non-invasive co-oximeter device for FDA 510(k) clearance.
Milestone Approvals Enable European and UK Market Access for AI-Based Cardiac Arrest Prediction Tool
Women can now collect their own sample from the privacy of home, no speculum required, and mail it to a certified lab to be tested on the same test as the doctor’s office, with the same accuracy.
Final approval clears the way for Zydus to market Glatiramer Acetate, expanding access to a key treatment for multiple sclerosis patients in the U.S.