In late January and with an eye on HIMSS 2011, Cisco's partner Extension Inc. issued a press release announcing that it had submitted its HealthAlert for Nurses offering to the FDA for clearance. Is said that the FDA could find no communications tool on the market that was "substantially equivalent" to HealthAlert for Nurses.

“This submission for FDA clearance culminates two years of research and tremendous effort designed to differentiate Extension from similar - but certainly not equal products - currently available in the marketplace," Extension CEO Todd Plesko stated in the release. "It also offers comfort to our growing hospital client base seeking to utilize their existing Cisco infrastructure and/or the emergence of smartphones, and serves as future-proofing for our clients and partners in the face of more FDA regulation in the middleware communication space. I think everyone in the industry agrees more FDA regulation in mobile health and communication is on the horizon. We’ve positioned ourselves well ahead of the pack both for Cisco IP-based handsets and smartphones."

This week a different middleware vendor in the clinician communications space announced an actual FDA clearance for its product -- not a submission -- a clearance, which might mean Plesko overstepped in his declaration that Extension was "well ahead of the pack," at least in terms of that specific FDA submission:

Ascom, which supplies mission critical on-site wireless communications, announced this week that ClinicalConneX|Cardiomax has received 510(k) clearance from the FDA's Center for Devices and Radiological Health (CDRH). According to Ascom: "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."

Last April Ascom hooked a big partner: GE Healthcare. The two announced a deal to integrate GE's patient monitoring platform with Ascom Wireless Solutions’ wireless VoIP phones, pagers and DECT handsets. The companies said the deal will enable hospitals to customize, filter and send secondary alarms to clinicians’ Ascom VOIP phones and other devices.

Ascom took the opportunity in its FDA clearance announcement to explain how it managed to get "ahead of the pack" as Extension's Plesko phrased it and emerge the more visionary:

"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's CEO and President Chad West stated in the press release. "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."

Other vendors that offer mission critical alarm systems will likely follow suit with FDA clearances soon. Philips Emergin, Amcom, Conexall -- who's next?