Sibel Health today announced FDA 510(k) clearance of ANNE® Maternal, the world’s first fully wireless, comprehensive maternal-fetal monitoring platform.
DALLAS, April 8, 2026 /PRNewswire/ — Dallas-based MedCAD has received FDA 510(k) clearance of its AccuStride® lower leg tibia and fibula system, making these patient-specific precision devices available to surgeons. The unique design of the custom-made planning and surgical guides will enable orthopedic surgeons to correct multiple related pathologies and osteotomies in a single procedure.
Research suggests that over 120,000 patients suffer from aortic arch disease in the US and Europe annually, but only around 25% of patients are diagnosed or treated.
Adagio Medical (Nasdaq:ADGM) announced today that it received FDA investigational device exemption (IDE) to expand its FULCRUM-VT trial.
BD (NYSE:BDX) announced today that it received CE mark approval for its Liverty TIPS stent graft system.
Supira Medical announced today that it received FDA approval to initiate a new trial of its percutaneous ventricular assist device (pVAD).
MILFORD, Mass., April 8, 2026 /PRNewswire/ — Waters Corporation (NYSE: WAT) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, marking a significant milestone in expanding access to cervical cancer screening, and removing barriers that currently prevent many individuals from receiving routine screening.
TriCares announced today that it received FDA investigational device exemption (IDE) to study its Topaz heart valve replacement system.
Encouraging 12-month pilot clinical study results will be presented by Key Opinion Leader Dr. Lowell Kabnick at the prestigious Charing Cross Vascular Symposium in London on Tuesday, April 21st, 2026.
Stereotaxis (NYSE:STXS) announced today that it received FDA 510(k) clearance for its Synchrony system.