Xenco Medical expands its ambulatory surgery center surgical device portfolio with the FDA clearance and launch of its Multilevel CerviKit.
Tag: FDA clearance
ALung Technologies, Inc., a provider of low-flow extracorporeal carbon dioxide removal technologies for treating patients with acute respiratory failure, announces that the U.S. FDA has granted the company De Novo clearance for the Hemolung Respiratory Assist System.Read More
Sibel Health announces that the U.S. FDA has granted 510(k) clearance to the ANNE One platform, a wireless, flexible, and rechargeable monitoring system indicated for the measurement of multiple vital signs in the healthcare setting.Read More
Delphinus Medical Technologies, Inc. announces that the U.S. FDA has granted premarket approval of its SoftVue 3D Whole Breast Ultrasound Tomography System for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue.Read More
Richardson, Texas-based Fuse Medical, Inc. announces that it has received U.S. FDA 510(k) clearance for its Tibial Revision Knee System and the PS Plus Posterior Stabilized Tibial Insert, the latest additions to the Sterizo Total Knee System.Read More