How HIPAA Security Paves Way for FDA Classification

According to an article from Healthcare IT News, “Broadly defined, software as a medical device is any application used by providers to make clinical decisions. An increasing number of applications are now officially designated as FDA-regulated devices.” ...

Crowdfunding Medical Devices Raises Money — and Questions

Crowdfunding is becoming more commonplace for new medical device innovations.  According to an article from the Boston Globe, ” A growing number of entrepreneurs rushing to peddle all manner of experimental medical devices on crowdfunding sites, a strategy more...

US Regulators Extend UDI Deadlines Following Security Issue

According to an announcement from Emergo, “Citing security vulnerabilities, the US Food and Drug Administration has extended deadlines for compliance with a key component of the agency’s Unique Device Identification (UDI) system.”  For more information on...

ICYMI: FDA Approves OxyContin for Pain in Kids 11 to 16

It was recently reported that “The Food and Drug Administration (FDA) on Thursday approved the powerful painkiller OxyContin for a new use in children 11 to 16 who are suffering from severe, long-term pain” according to the Seattle Times.  For more...

FDA Launches Open-Source Platform for Precision Medicine

According to MedCityNews.com, ” It’s called precisionFDA, and will be the newest cog in the White House’s Precision Medicine Initiative.  It’s planned for beta release in December this year, and is being developed by Bay Area startup DNAnexus. In a blog,...