AliveCor gets FDA clearance for two new automated detectors
The Normal Detector identifies when no abnormalities are detected in an ECG, while the Interference Detector identifies if factors have affected the recording.
FDA approves Dexcom G4 Platinum Continuous Glucose Monitoring System with Share
The device uses secure wireless connection between a patient's receiver and mobile app to transmit glucose information to apps on the mobile devices.
FDA unveils guidance on regulation of wellness devices and accessories
These products maintain or encourage a general state of health and may associate a healthy lifestyle with reducing the risk or impact of certain diseases or conditions.
LifeWatch’s Vital Signs Patch gets FDA 510(k) clearance
Once the device is activated and connected with the supporting system, it provides automation and alerts of key vital signs via continuous wireless monitoring.
LG Smarthealth receives FDA clearance
The company's next year's device may take a step forward and integrate heart rate monitor, which is already found in few Samsung handsets.
FDA approves Dexcom’s software with new pancreas algorithm
With the new software, healthcare providers, patients and caregivers will now have glucose readings from a sensor that are closest yet to lab accuracy.
Dexcom SHARE receives FDA approval
The remote mobile communications device used for Continuous Glucose Monitoring (CGM) has cleared the regulatory hurdle and is now ready to be sold in the U.S.
AnthroTronix’s brain health assessment app DANA receives FDA clearance
The application is indicated for use as part of any clinical assessment where concerns for changes in cognitive or psychological status are present.
Covidien’s Nellcor Portable SpO2 Patient Monitoring System gets FDA 510(k) clearance
This is the only portable oximeter indicated for use in home care settings and is compliant with international standards for devices used in home health care.
Philips secures FDA’s 510(k) clearance to two of its telehealth apps
eCareCoordinator and eCareCompanion are the first clinical applications to be available through the cloud-based digital health platform.