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FDA

By Jonah Comstock | 10:15 am | December 01, 2014
South Korean technology company LG Electronics has received an FDA 510(k) clearance for something called "LG Smarthealth".
By Jonah Comstock | 01:40 pm | October 20, 2014
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.
By Jonah Comstock | 09:18 am | October 07, 2014
Urine analysis app uChek is about to launch a six-month, 375-patient trial with Merck for Mothers, a Merck-sponsored initiative to reduce global maternal mortality, according to ClinicalTrials[dot]gov.
By Jonah Comstock | 12:48 pm | September 10, 2014
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.
By Jonah Comstock | 09:46 am | August 25, 2014
Joining the ranks of Google and Apple, online retail giant Amazon has met with the FDA, according to the agency's public calendar, according to a report in Modern Healthcare.
By Jonah Comstock | 11:26 am | July 16, 2014
Australian company dorsaVi has received FDA clearance for its ViMove sensor system.
By Jonah Comstock | 06:00 am | July 03, 2014
Waltham, Massachusetts-based EarlySense, which makes a passive and contactless bedside monitor that continuously measures respiration rate, heart rate and motion, has received a new FDA clearance for a sensor designed to work with not a bed, but a chair.
By Jonah Comstock | 11:20 am | June 18, 2014
The FDA has, at long last, released draft guidance for how pharmaceutical companies should behave on limited-character social media platforms like Twitter and when correcting misinformation on third-party sites.
By Brian Dolan | 02:38 pm | December 01, 2009