The focus of the Pre-Cert program is not on particular products but on firms and developers, which in turn (if pre-certified) will be able to more easily certify all of their products.
This is the first spirometer that was specifically developed as a home-use wireless connected spirometer that works with computers and mobile devices.
The device is available for purchase starting today, for $59.99 in-store at Best Buy and online at various retailers.
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.
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.
QbCheck provides unbiased and objective outcome measurements that can be utilized quickly and easily so that professionals are informed to act in ADHD.
Triggerfish contact lens can detect the peak patterns of variation in intraocular pressure to identify the window of time to measure intraocular pressure.
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.
The company's wireless, patch-based system makes vital signs monitoring faster, easier and more convenient for both patients and medical staff.
The company also announced that it will suspend its current home sleep testing services while it explores new innovations and options...