FDAnews Device Daily Bulletin

Lawmakers and watchdog groups are putting a brighter spotlight on the FDA, demanding the agency, HHS and the White House take action to ensure whistleblower protections and investigate allegations of inappropriate email monitoring by the drug regulator.

The FDA needs to insist on more quality data in 510(k) premarket notification and premarket approval (PMA) applications and provide real-time postmarket surveillance data that is transparent, Rita Redberg, chief editor of the Archives of Internal Medicine and professor of medicine at the University of California, San Francisco, told the 2012 PharmedOut Conference in Washington, D.C.

Covidien won Brazilian regulatory approval for its Solitaire FR revascularization system as a device to clear blood clots from the brain in patients suffering from acute ischemic stroke.

The higher prevalence of cardiovascular diseases has become a cause of concern for the U.S. healthcare authorities as mortalities tend to rise and economic burdens keep increasing.

Should all U.S. children get tested for high cholesterol? Doctors are still debating that question months after a government-appointed panel recommended widespread screening that would lead to prescribing medicine for some kids.

Restoration Robotics announced the first use of its ARTAS System in North Carolina.

A new way of processing embryos during IVF treatment can improve the chances of pregnancy by more than a quarter, The Daily Telegraph today reported.

The inquiry committee headed by Dr Gills George to probe into the deaths of three persons at the Cooperative Medical College Hospital, Kalamassery, submitted its report on Monday.