Ascom Holding AG

12/06/2018 | Press release | Distributed by Public on 12/06/2018 00:03

The Ascom Digistat Smart Central clinical software solution receives FDA clearance in the United States

Ascom has reached an important strategic milestone by receiving clearance from the U.S. Food and Drug Administration (FDA) for its Digistat Smart Central software solution. The development further strengthens and differentiates the Ascom Healthcare Platform in the United States.

The FDA clearance permits Ascom to offer the intuitive clinical alarm workflow management software solution Digistat Smart Central, as well as Digistat Smart Central Mobile, in the US market as a class II 510(k) device for use with patient monitors, infusion pumps and ventilators. This clearance, together with the earlier FDA clearance of Ascom Unite Connect for Clinical Systems, allows Ascom to increase the scope of the Ascom Healthcare Platform for hospitals in the United States.

Already implemented in leading hospitals in Europe, Digistat Smart Central is designed to provide an overview of clinical device status. It provides near real-time physiological information to clinicians, and highlights alarms possibly occurring on the connected devices. Digistat Smart Central supports the improvement of clinical workflows related to the management of medical devices alarms.

'With this FDA clearance, Ascom has reached an important landmark as a leader in healthcare workflow solutions in the United States. The ingenuity and comprehensiveness of our Ascom Healthcare Platform meet the needs of our valued US customers in the healthcare industry. We look forward to making workflows in hospitals more efficient and reliable in a sophisticated way with the goal of improving patient outcomes and the well-being of clinical staff,' emphasizes Holger Cordes, CEO of Ascom.