The US Government Accountability Office (GAO) said in March 2016 within a new report that it’s still too early to assess whether the Food and Drug Administration’s (FDA) three-year-old pediatric priority review voucher (PRV) program has stimulated the development of drugs to treat or prevent rare pediatric diseases.
Japanese researchers have developed a highly sensitive electronic stethoscope to record and then analyze patient breathing sounds for diagnosis into 5 common categories. A team of three physicians from Hiroshima University and Fukushima Medical University developed the system in collaboration with corporate partner Pioneer.
Amid a growing body of research on heart health devices and blood pressure monitoring, a new report from Blue Cross Blue Shield shows that women undergo fewer diagnostic procedures and treatments following a heart attack than men.
A large study funded by the National Institutes of Health (NIH) found that a drug-delivering vaginal ring could protect some women against HIV. The results come on the heels of more promising data, which show that the ring device can reduce women’s risk of developing the infection.
As part of the 14th round of ongoing negotiations of the Transatlantic Trade Investment Partnership (TTIP) between the US and EU, the European Commission has released a new proposal that would push for more collaboration on medical device regulations.
The US Food and Drug Administration (FDA) in July 2016 issued two draft guidance documents describing how the agency will restrict the compounding of drugs that are essentially copies of commercially available or approved drugs.
Scientists are racing to develop quick diagnostic devices that can screen for potentially deadly diseases in developing countries. Now, some researchers moved one step forward in the field with a portable microfluidic device that can screen for the Ebola virus.
Scientists from Wake Forest Baptist Medical Center have proven that they can 3-D print living tissue structures, including ear, bone and muscle, which may be used to replace tissue on human patients. The research team published a paper in the journal Nature Biotechnology showing that they were able to 3-D print human-scale tissues and then effectively implant them in mice to result in vascularized, functional tissue.
Adverse events and recalls aren’t always proof of a mechanical error. Some devices are difficult to use. Human error and patient harm can stem from unclear electronic interfaces or complicated procedures for use.
Interoperability is an increasingly important component of med tech, due to the need for communication and data exchange within a networked system of other devices, electronic health records and clinicians. Poor interoperability is blamed for problems like “alarm fatigue” whereby poorly networked devices produce an excessive number of loud warnings out of an abundance of caution, leading to the risk that a necessary alarm will be ignored.