GoSpiro home-use spirometer

Monitored Therapeutics’ GoSpiro Home Spirometer clears the FDA

This is the first spirometer that was specifically developed as a home-use wireless connected spirometer that works with computers and mobile devices.
John Bedell Photography

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.
IBM Blockchain

IBM Watson Health, FDA to study the use of blockchain for secure exchange of...

The two parties will explore the exchange of data from several sources, such as EMRs, clinical trials, genomic data, and health data from mobile devices.
Proteus Digital Health

FDA asks for more tests before it approves Proteus-Otsuka’s sensor-equipped pill

The two companies submitted the system as a new drug application (NDA) with the FDA in September 2015, and the Agency now declined to approve it.
QbTest

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.
Triggerfish smart contact lens

Connected contact lens that tracks glaucoma progression clears the FDA

Triggerfish contact lens can detect the peak patterns of variation in intraocular pressure to identify the window of time to measure intraocular pressure.
MoMe Kardia

InfoBionic’s MoMe Kardia receives FDA 510(k) clearance

The device acquires and stores ECG and motion data and transmits that data via embedded cellular technology to the cloud-based platform MoMe Software System.
LifeWatch

FDA clears LifeWatch’s continuous Vital Signs Monitoring Service

The company's wireless, patch-based system makes vital signs monitoring faster, easier and more convenient for both patients and medical staff.
LifeWatch HeartPatch

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...
Quell

Next-gen Quell wearable pain relief device clears the FCC

The new model will be available in March, featuring extended battery life, advanced sleep tracking, and the ability to control Quell from a mobile app.