Hacking into a Remote-Controlled Medical Device is Not Science Fiction Anymore

Exactly 20 years ago, in late July 1995, Hollywood movie, The Net was released with Sandra Bullock in the lead role. The movie led to many predictions such as widely available wireless internet, interconnected information portals, even online pizza ordering (Pizza Hut and Dominos it seems like got their idea for online order from that movie). In one … Read more

Medical Device Labeling in FDA’s Cross-Hair

FDA does not have a process for formal review of labels or advertisement material for approved medical device intended for patients and lay caregivers. Most Class I and several Class II devices do not require a doctor’s supervision to buy or use a given medical device. Historically, it was acceptable as most medical devices are used under supervision … Read more

Abuse Deterrent Technology Comes of Age in Opioid Formulation

The death toll from prescription opioids abuse has been soaring around the world over the past 20 years. It now exceeds fatalities from road accidents or deaths from heroin and cocaine in the United States, the United Kingdom and Australia according to a recent article in Nature magazine. As discussed in the article, some of the more promising … Read more