FDA clears Ascom's ClinicalConneX | Cardiomax medical device

Ascom (US) Inc., a leading supplier of mission critical on-site wireless communications, is pleased to announce ClinicalConneX as its new integration suite powered by Ascom's Unite Professional Messaging and Alarm Application. ClinicalConneX | Cardiomax is the first Ascom medical device cleared by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH).

Cardiomax is a component within the ClinicalConneX integration suite and provides an interface to Patient Monitoring Systems that forward alarm information to Ascom handsets or a wide variety of display devices, including pagers, mobile handsets and LED signs. It provides near real time alarms intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events captured by Patient Monitoring Systems. The display device can provide a combination of visual, audio and vibratory awareness mechanisms upon receipt of the secondary alert notification. ClinicalConneX | Cardiomax has been designed to integrate with a variety of both standards-based and proprietary Patient Monitoring Systems.

According to Chad West, President and CEO of Ascom (US) Inc., "Our receipt of FDA 510(k) clearance to legally market Ascom's ClinicalConneX | Cardiomax solutions means that hospitals will now have the capability to deploy an FDA-cleared solution. Two years ago, we recognized the need to proactively respond to the then proposed FDA MDDS rule. Now that the final MDDS rule has been published and it excludes active patient monitoring, it is clear that we made the proper decision pursuing a predicate product code that specifically addresses integrating with patient monitoring devices. Ascom offers its own market-leading VoWiFi and IP-DECT wireless handset devices so hospitals can rely on a single supply partner for deploying a complete end-to-end solution. Additionally, we realize that many hospitals have existing wireless platforms so we also offer integration with wireless devices with other suppliers, such as Polycom SpectraLink^® and Cisco^®, further demonstrating our device-agnostic approach to mission-critical alarm messaging."

Ascom began the design of ClinicalConneX | 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. ClinicalConneX | Cardiomax was cleared by the FDA utilizing predicate product code MSX: Physiological Cardiac Monitoring medical devices which utilize system, network and/or communication systems. Ascom designed, developed, verified and validated ClinicalConneX | Cardiomax within a Quality Management System (QMS) designed to comply with the FDA Quality System regulations 21 CFR §820 (cGMP/QSr), the International Organization for Standardization ISO 9001: 2008, and the International Organization for Standardization ISO 13485: 2003. Implementation of the QMS has enabled Ascom to provide quality products and services to healthcare customers throughout the United States and Canada.