Global Kinetics Corporation’s Personal KinetiGraph clears the FDA
Said device is designed to improve the assessment and monitoring of symptoms of Parkinson's disease and other neurological disorders that affect movement.
Otoharmonics’ Levo System receives FDA 510(k) clearance
Levo identifies and maps an individual's unique sound print using custom-fit ear buds and proprietary software on iOS devices.
Vital Connect HealthPatch MD biosensor gets FDA clearance for home monitoring
The device weighs only 10 grams and is only 6 mm thick, making it comfortable for patients and less obtrusive than conventional monitoring equipment.
Amazon eyeing the digital health sector
The online retail giant has recently met with the FDA but what the two parties discussed is unknown; is Amazon looking to create a HealthKit-like service?
AliveCor gets FDA clearance to detect a serious heart condition
The company's algorithm can detect if patients are experiencing AFib through real-time ECG recordings taken on the mobile phone with AliveCor Heart Monitor.
Philosys’ Gmate SMART Blood Glucose Monitoring System gets FDA 510K approval
Gmate SMART meter connects to the headphone jack of an iOS device and with an accompanying mobile app, it delivers accurate and fast blood glucose results.
Philips’s ultra mobile VISIQ ultrasound system receives FDA 510(k) clearance
Transducer-plus-tablet display delivers excellent image quality, making ultrasound available anytime, in a wide range of clinical environments for OB patients.
mHealth app market needs regulation for consumer safety and confidence
Most consumers think that because an app is available through a trusted retailer, they must have been reviewed by the FDA, which isn't usually the case.
FDA clears EarlySense’s Chair Sensor Solution
The "smart chair" continuously monitors patient's vital signs, allowing clinicians to proactively respond to early signs of patient deterioration.
Nexus6’s Smartinhaler clears the FDA hurdle
Smartinhaler installs on to a patient's inhaler to record the date and time the inhaler is used, and can then send that information to other devices.