ORA Reorganization Includes New Geographic Divisions for Devices

The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure Monday, aligning inspection staff into seven product categories — and creating three new geographic divisions for oversight of devices.

Graphene-based sensor could help ward off asthma attacks

Scientists at Rutgers University-New Brunswick have created a graphene-based sensor that could lead to a wearable device that when blow into predicts the likelihood of an asthma attack.

Connected thermometer data used to predict flu outbreaks

Researchers have used data gathered by connected thermometers to predict the onset of an influenza outbreak.  An analysis of data from users of the iThermometer wearable and its companion app in China predicted the spike in the 2015-16 flu season one month before the country’s public health body.

Can aging muscle be regenerated? New research suggests a first step

Scientists at Sanford Burnham have identified the mechanism that causes muscle cells to stop regenerating as people age.  This knowledge could lead to methods to slow — but not stop — the decline in muscle mass and function people experience as they get older.

WannaCry ransomware infected Bayer U.S. medical devices

The WannaCry ransomware attack that took out the United Kingdom Healthcare Service (UKHS) also hit at least two Bayer medical devices in the U.S., Forbes reports.  An image received by the business magazine shows the now-familiar WannaCry ransom message obscuring the display of a Bayer radiology system.

Limited domestic vaccine manufacturing endangers U.S. flu prep, GAO report says

The U.S. could run into a vaccine supply predicament if an influenza pandemic hits, since only one drug maker has a U.S. facility with egg-based vaccine production capabilities.  Furthermore, the situation could be even more serious if the epidemic comes from an Avian Flu, which could infect the very same hens that supply the eggs used for vaccine development.

Diabetes drug Metformin shows promise in treating one form of autism

Metformin has been helping patients with Type 2 diabetes control their blood sugar for more than two decades; however, now researchers led by McGill University are investigating a new use for the drug:  to treat fragile X syndrome, which causes some forms of autism.