Ascom achieves Medical Device Directive in Europe and FDA clearance in the United States
Ascom announced today that their Wireless Solutions division has received medical device clearance on two different products targeted to the European and United States markets. This is in line with their mission to become the international leader in healthcare communication by 2013.
The Ascom Mobile Monitoring Gateway (MMG) received Medical Device Directive clearance by the Swedish Medical Products Agency valid for whole Europe (Medical Device Directive 93/42/EEC) in April 2011. In March of this year, the Ascom Cardiomax was the first Ascom medical device to be cleared by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). Both products cover the same functional scope for hospital customers.
"We are seeing increased customer sensitivity to medical device directives and legislation and expect higher demands for approved product for delivery into hospitals and other healthcare institutions," says Fritz Mumenthaler, CEO for Ascom. "Ascom is committed to providing and improving the mission-critical wireless solutions that help clinicians improve patient healthcare. We expect more regulations of mobile medical solutions and Ascom will continue to be proactive in this area as increasing patient safety is one of our utmost concerns."
The Ascom Mobile Monitoring Gateway was developed in cooperation with General Electric' Healthcare Division and provides an interface between GE Healthcare CARESCAPE Network and Ascom Unite Professional Messaging and Alarm Suite. It enables hospitals to customize, filter and send secondary alarms to inform healthcare professionals of particular medical related events captured by the GE Healthcare CARESCAPE Network. The alarm is forwarded to Ascom handsets or a wide variety of display devices, including pagers, mobile handsets and LED signs.
For the United States healthcare market Ascom began the design of Ascom Cardiomax in early 2010 with the intention of developing a product that would meet or exceed the regulatory guidelines and/or proposed rules that are outlined by the FDA for implementation within the healthcare environment. The Cardiomax solution has been designed to integrate with a variety of both standards-based and proprietary patient monitoring systems including Space Lab, Nihon Kohden, and Mindray Patient Monitoring Solutions with additional monitoring system verification and validation currently underway.
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