FDA mHealth

By Brian Dolan 07:26 am February 15, 2011
By Bradley Merrill Thompson, Epstein Becker & Green, P.C. To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, a middle and an end. They paint an entire picture. Unfortunately, reading the MDDS rule is like reading just the middle of the story --...
By Brian Dolan 04:15 am December 23, 2010
The US Food and Drug Administration (FDA) announced last week that it had granted Zephyr Technology 510(k) clearance for its remote patient monitor system, which was the same technology used to monitor the Chilean miners who were trapped after a cave-in at the San José copper-gold mine in the Atacama Desert this past August. Zephyr's systems have also been used by "warfighters, first responders...
By Brian Dolan 05:34 pm August 2, 2010
Topol joins CHI board: California Healthcare Institute announced today that Dr. Eric Topol, director, Scripps Translational Science Institute; chief academic officer, Scripps Health; and vice chairman, West Wireless Health Institute has been elected to its board of directors. More BlackBerry + Digital Pen Combo: Clinicians at UK's Portsmouth Hospitals Trust are piloting a digital pen - Blackberry...
By Brian Dolan 01:09 pm July 7, 2010
Honolulu, Hawaii-based Kai Medical received 510(k) clearance from the Food and Drug Administration to market an updated version of its wireless respiratory rate monitor, Noncontact Respiratory Spot Rate Check 200. Kai claims that currently approaches for measuring respiratory rate are difficult, which leads this vital sign to be inaccurately measured, infrequently measured or inconsistently...