Tag: FDA clearance

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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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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