Global Kinetics Corporation's Personal KinetiGraph clears the FDA

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.
Levo System receives FDA 510(k) clearance

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.
HealthPatchMD

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

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 Heart Monitor

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.
Gmate SMART Blood Glucose Monitoring System

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 VISIQ

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.
FDA

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.
EarlySense

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.
SmartTouch inhaler monitoring device

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.