Category: Clearances

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 OKs ‘Major Advancement’ in CT Technology

The U.S. FDA says that it has granted 510(k) premarket clearance to what it deems the “first new major technological improvement for CT imaging in nearly a decade”—Siemens Healthineers’ Naeotom Alpha CT scanner.

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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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