Patient monitoring system earns FDA clearance

North Carolina-based wireless communications company Ascom announced Monday that Cardiomax, a patient monitoring component within its ClinicalConneX integration suite, received 510(k) clearance from the Food and Drug Administration as a medical device. Now, the company is looking to deploy its system nationwide, reports MedCity News.

Specifically, Cardiomax will allow for alarm information to be forwarded to all Ascom handsets, as well as pagers, mobile handsets and LED signs, the company said in a statement. Essentially, bedside monitoring alarms can be forwarded throughout an integrated system, helping multiple providers to be more connected when it comes to patient care.

Under the new Medical Device Data Systems rule, Cardiomax is considered a class I device, meaning it is regarded as low-risk and is exempt from premarket review. Ascom U.S. CEO Chad West told MedCity he assumed as much would happen, and thus filed for the clearance prior to the finalization of the rule.

"We've got a bit of a first mover's advantage, for a little while anyway," West said.

Ascom plans to deploy the system to nationwide in the near future, according to MedCity.

To learn more:
- here's the announcement
- read this MedCity News article

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