Intelesens’ zensor gets FDA 510(k) clearance
The small device can be worn for seven days at a time, while collecting data on respiration rate, three-lead ECG, heart rate and motion.
FDA’s new app lets physicians report novel uses of existing medicines
CURE ID allows the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing drugs.
FDA to simplify the use of foreign clinical trial data for medical device makers
The FDA wants that medical device clinical trials conducted outside of the US are either equal to or greater than US requirements for human protection.
LifeWatch’s MCT 1-Lead Patch clears the FDA
The company also announced that it will suspend its current home sleep testing services while it explores new innovations and options...
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.
Dexcom G5 Mobile CGM system clears the FDA
This is the first and only full mobile CGM system that allows adults and children as young as 2 years old to conveniently monitor and share glucose levels.
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.
FDA clears an online tool for diagnosing ADHD
QbCheck provides unbiased and objective outcome measurements that can be utilized quickly and easily so that professionals are informed to act in ADHD.
FDA clears VivaLnk’s wearable thermometer Fever Scout
The device is available for purchase starting today, for $59.99 in-store at Best Buy and online at various retailers.
Viatom’s Checkme Pro medical tricorder clears the FDA
The device can perform one-lead ECG recording, pulse oximetry, temperature measurement, and movement sensing, among other things.