A Look at CDRH's Priorities for 2014
A new Web site mandated by the Medical Device User Fee Amendments of 2012 reveals some of the guidances and draft guidances on CDRH's to-do list for 2014.
The Global Medical Device Regulatory Environment
Despite uncertainty in the EU and a continued lack of transparency in some of the BRIC countries in 2013, medical device regulatory agencies are making significant strides in harmonization efforts.
Frustration Marks the Tone In Which FDA Issues Warning Letter to 23andMe
In a warning letter, that expressed frustration as the overwhelming emotion more than anything else, the FDA asked 23andMe, the much-talked about genomics testing company, to immediately stop selling its Personal Genomics Service (PGS) and Saliva Collection Kit.
The letter, dated Nov. 22, narrate...
In Five Years, Shipments of Wearable Technology Will Jump 8-Fold (infographic)
Wearable sensors, trackers and other such technolohgy are reshaping the healthcare industry as there is growing potential to change unhealthy behaviors through more information gleaned from these products.
So much so that the infographic below predicts that in five years, the amount of money that c...
Developer of Wearable Infant Monitor Raises $1.2 million
Being parent of a newborn, especially if it's your first child when you are unsure about most things, can be very stressful.
One company that is aiming to soothe parents by designing a wearable infant monitor that can tell parent about how the status of the infant is Boston-based Rest Devices.