FDA clears new mammography system from Siemens Healthineers
April 4, 2024
Siemens Healthineers announced today that it received FDA 510(k) clearance for its MammoMat B.brilliant mammography platform.
Siemens Healthineers announced today that it received FDA 510(k) clearance for its MammoMat B.brilliant mammography platform.
Benefits of the system, according to a news release, include maneuverability and visualization.
FixNip NRI is a nipple implant for women who have undergone breast reconstruction surgery
One panelist who voted yes said the “incremental benefits outweigh the small risks of anaphylaxis.”
Roche Diagnostics has announced CE mark approval for a claim extension to the Elecsys Anti-Müllerian Hormone (AMH) Plus immunoassay. The claim extension means that the blood test, already available on the NHS, can now be used by physicians to help diagnose women suspected of having polycystic ovary syndrome (PCOS) as an alternative to a transvaginal ultrasound.
A research team from Odense University Hospital and the University of Southern Denmark has developed an innovative screening test. With a blood sample from the expectant mother, they can scrutinize all the genes in the fetus.
MINNEAPOLIS, Dec. 19, 2023 /PRNewswire/ — ShiraTronics, Inc., a trailblazing clinical-stage medical device company, today announced a landmark achievement with the successful implantation of its Chronic Migraine System in the world’s first six patients. This remarkable milestone represents a significant leap forward in neuromodulation, as the company unveils the first-ever fully implantable system for head location utilizing a minimally invasive approach.
RTI Surgical, a leading global medical device organization, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for a clinical study designed to confirm the safety and effectiveness of Cortiva® Allograft Dermis in implant-based breast reconstruction.
24-month data shows UI symptom relief is durable, and early data shows symptom relief for pelvic organ prolapse