New regulations governing the pathway for new innovative medical devices will come out on Wednesday, President Obama announced Tuesday. Changes to the 510(k) program will be released by the U.S. Food & Drug Administration’s Center for Devices and Radiological Health.

Dr. Deborah Rhodes spoke in early December at TEDWomen, one of a series of events that highlights innovative thinkers and “ideas worth spreading.” Since the speech was posted online late last week, it has become one of TEDWomen’s “most emailed” and has caused a deluge of interview requests, said a Mayo spokesperson. In her talk, Rhodes zeroed in on the center of recent controversy and confusion over mammogram guidelines: breast density.

The latest US healthcare reform bill, in this case the Republican’s attempt to repeal the current healthcare reform law, actually cuts benefits for the uninsured while growing the inefficient parts of Medicare. It increases Medicare spending over 10 year by $500 billion.

FDA Deputy Commissioner Dr. Joshua Sharfstein will be replaced, at least temporarily, by John Taylor, the FDA’s Counselor to the Commissioner. He will be in an acting role for the next two months.

The Wall Street Journal is reporting that the U.S. Food & Drug Administration deputy commissioner, Joshua Sharfstein, will leave to become secretary of health and mental hygiene for Maryland. Sharfstein has been the point man for the FDA on many key safety issues.

The Health Information Technology for Economic and Clinical Health Act, which was part of 2009′s Stimulus bill, stipulated that healthcare providers can receive up to $44,000 through Medicare or as much as $63,750 through Medicaid if they implement and prove so-called “meaningful use” of an EHR system. Under both Medicare and Medicaid, hospitals are eligible for millions of dollars if they complete the EHR programs’ requirements.

U.S. Food and Drug Administration regulators last year said fillings that included mercury-based metals were safe. Now the FDA will hold public meetings to further probe the issue, focusing particularly on children and pregnant women.

A Virginia judge has struck down an important part of US healthcare reform. But losing the individual mandate shouldn’t necessarily destroy “ObamaCare.” A mix of new policies – include leveraging Medicaid rules and changing emergency room restrictions – could also get the job done.

Minnesota Sens. Amy Klobuchar and Al Franken along with Rep. Erik Paulsen have championed the medical device industry, giving speech after speech and writing letter after letter to the Food and Drug Administration about upcoming changes to its 510(k) approval program. I doubted the campaign would do much. But Wednesday, a bipartisan group of 15 senators sent a letter to FDA Commissioner Dr. Margaret Hamburg urging her agency, among other things, to adopt a more deliberate, cautious approach to amending 510(k).

Despite its moniker, the Food and Drug Administration (FDA) has been more drug (and device) than food in recent years. One major reason: the agency competes with several federal agencies, including the Department of Agriculture and Environmental Protection Agency, to oversee the nation’s food supply. It’s a confusing and ultimately self-defeating tangle of bureaucracy and overlapping authority.