My wife complains I live in the future, and I suppose that’s true. But on the heels of three days of hearings last week by two subcommittees of the House Energy and Commerce Committee, all focused on ...

Perhaps more than any other metric, the time it takes to secure clearance is the one that gets the most attention for 510(k) devices. An updated analysis from medical device quality assurance and ...

LOS ANGELES (Reuters) - A fast-growing number of software applications offers doctors the chance to view X-rays or monitor heart rates from iPads or smartphones, prompting U.S. health officials on ...

The U.S. Food and Drug Administration has issued final guidance for mobile medical application developers, promising limited regulation for most health and wellness apps while applying risk-based ...

A National Cancer Institute program manager warned about mobile applications that promise health care benefits to consumers without being backed by scientific data. Health IT HHS The performed at ...

The U.S. Food and Drug Administration intends to regulate only mobile apps that are medical devices and could pose a risk to a patient’s safety if they do not function as intended. Some of the risks ...

The mHealth Regulatory Coalition (pdf) and Healthcare Information & Management Systems Society have separately submitted comments on the FDA’s draft guidance for mobile medical applications, according ...

The FDA's recent guidance on mobile medical apps creates a gray area in which the agency will not automatically require approval for all new mobile medical apps, but may exercise "enforcement ...