FDA Clears Xenco Medical’s New Spinal Surgical Device
Xenco Medical expands its ambulatory surgery center surgical device portfolio with the FDA clearance and launch of its Multilevel CerviKit.
Tag: FDA clearance
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FDA Clears Peripheral Vascular Occlusion Device
The U.S. FDA provided clearance for Artio Medical's Solus Gold Embolization Device, a peripheral vascular occlusion product.
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FDA Clears Abbott’s New Cardiac Mapping System to Treat Abnormal Heart Rhythms
Abbott has received FDA clearance for a new cardiac mapping platform that is designed to help physicians better treat abnormal heart rhythm.
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FDA Clears Xenco Medical’s New Spinal Surgical Device
Xenco Medical expands its ambulatory surgery center surgical device portfolio with the FDA clearance and launch of its Multilevel CerviKit.
FDA Grants De Novo Clearance to Respiratory Device
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.
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Fujifilm Launches Dual-Channel Endoscope
Fujifilm’s EI-740D/S is a dual-channel endoscope cleared by the U.S. FDA for use in both upper and lower gastrointestinal applications.
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FDA Clears Wireless Vital Signs Monitoring Platform
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.
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FDA OKs Whole Breast Ultrasound Tomography System
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.
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FDA OKs Siemens Healthineers CT Scanner
Malvern, Pa.-based Siemens Healthineers announces that the U.S. FDA has cleared SOMATOM X.ceed, a single-source CT scanner that combines high-speed scanning capabilities with a new hardware/software combination to streamline CT-guided interventions.
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FDA OKs Sterizo Tibial Revision Knee System, PS Plus Posterior Stabilized Tibial Insert
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.
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Zimmer Biomet Nabs FDA Clearance for ROSA Hip System
Warsaw, Ind.-based Zimmer Biomet Holdings, Inc. announces that the U.S. FDA has granted 510(k) clearance to the ROSA Hip system for robotically assisted direct anterior total hip replacement.
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