FDA 510(k) clearance

In the last two months, the FDA has cleared a number of clinically-focused mobile health devices.

In March, Roche received FDA clearance for its Accu-Chek Connect companion app, and, less than a month later, issued a recall of that app.

Rochester, Minnesota-based Mayo Clinic spin-off Ambient Clinical Analytics has received FDA 510(k) clearance for a software-based decision support tool, called AWARE.

Sense4Baby, the maternal and fetal monitoring product developed by West Health and then acquired by AirStrip Technologies, has received a second FDA 510(k) clearance, which will allow pregnant mothers to perform non-stress tests in their homes.

A California hospital has begun requiring certain patients use a wearable remote patient monitoring device in order to comply with internal patient safety protocols.

Dexcom Share, a cradle device that will allow users to send data from a Dexcom continuous glucose monitor to multiple smartphones, has received 510(k) clearance from the FDA.

MobiHealthNews has been tracking FDA clearances for smartphone-connected medical devices and standalone apps for many years.

Yet another clinically-focused, activity tracking wearable has now been cleared by the FDA, this one aimed specifically at the monitoring and treatment of Parkinson's disease.

Severna Park, Maryland-based mobile sleep apnea-focused company Appian Medical has raised $580,000 from angel investors to conduct validation studies and apply for FDA 510(k) clearance for its app.

Australian company dorsaVi has received FDA clearance for its ViMove sensor system.