Aevice wins FDA nod for smart wearable stethoscope for pediatric patients
May 19, 2025
Aevice Health announced today that it received FDA 510(k) clearance for its AeviceMD smart wearable stethoscope device.
Aevice Health announced today that it received FDA 510(k) clearance for its AeviceMD smart wearable stethoscope device.
ATLANTA, May 13, 2025 /PRNewswire/ — KNoW Biological has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). This designation is an FDA program designed to expedite the review of devices and medications for serious or life-threatening conditions where there’s preliminary evidence suggesting substantial improvement over existing therapies on the market.
A patient-first solution redefines comfort and accuracy in sleep disorder testing across the U.S.
Align Technology’s non-invasive orthodontic innovation set to transform pediatric care in China.
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.