FDA clearances

The d-Nav Insulin Guidance Service was also the focus of a multi-center, randomized control trial published last week in the Lancet.

The new technology will be integrated into the connected MightSat Rx finger pulse oximeter. 

The prescription device detects each use and records it to a paired mobile app. 

The regulatory changes also come alongside Pre-Cert Program updates and roughly a dozen noteworthy digital health approvals.

The HeartGuide watch uses a flexible synthetic band to inflate and maintain its shape to comfortably take an oscillometric wrist blood pressure on the fly.

toSense’s CoVa Monitoring System 2, a remote patient monitoring necklace that tracks vitals and cardiac fluids, has received a second FDA clearance.

Over the past year, MobiHealthNews has covered 36 devices that received clearance from the Food and Drug Administration.

FDA clearances for digital health devices are on track to triple by 2018, according to new research from Accenture, as digital health offerings drive more than $100 billion in savings over that same time period.

As expected Australia-based medical device company dorsaVi has received a new FDA 510(k) that expands the use case for the suite of wearable sensors, called ViMove, to allow providers to use them for tracking additional static postures like a natural standing posture and various sitting postures.

By Bradley Merrill Thompson With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app.