FDA nod for LifeWatch wireless, patch-based vital signs monitoring system

Swiss remote diagnostic monitoring company LifeWatch has secured a clearance from the FDA for its wireless, patch-based vital signs monitoring system. It's expected to be used first in medical facilities such as hospitals and nursing homes, but eventually the company expects to target the ambulatory care market as well.

The Vital Signs Patch is worn on a patient's upper chest. In adult patients in a clinical environment, it offers continuous, noninvasive monitoring of ECG, heart rate, respiration rate, surface temperature, arterial blood oxygen saturation and body position. It will be available in two versions, with and without the ECG component.

 

Please click here to read more.

FDA clears app to monitor brain health on the battlefield

After being tested in Afghanistan for use in military settings, the FDA has cleared the DANA (Defense Automated Neurobehavioral Assessment) mobile assessment tool for measuring reaction time. Reaction time can be a sign of brain injuries that are common on the battlefield such as concussion, dementia, post-traumatic stress and depression, says product developer AnthroTronix.
"In essence, measuring reaction time is like taking the temperature of the brain--like a 'Brain Thermometer'--and it is a vital part of the data that a health professional needs to evaluate their patient," said AnthroTronix CEO Corinna Lathan in a statement.
The app will be offered on the Android and iOS operating systems over either mobile phone or tablet. AnthroTronix says the tool's mobility allows it be used soon after events such as exposure to an improvised explosive device bomb blast.

To find out more, click here.

FDA Unique Device Identification 2015

To find out about the FDA's 2015 plans for Unique Device Identification, please click here.