Toyota developing wearable device to improve mobility for the blind
Toyota, yes, the car company, is developing a wearable device to improve mobility among the blind.
Senators butt heads over proposed device (and drug) industry regulatory overhaul
When the business-friendly 21st Century Cures Act to overhaul regulation of the device (and drug) industry in July passed in the House by a bipartisan, 344-77 vote, anticipation rose that the most significant regulatory reforms in many years were on their way.
FDA Calls for End to Priority Review Vouchers as GAO Says Too Early to Gauge Effectiveness
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.
Researchers develop electronic stethoscope, analytics to aid lung diagnoses
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.
Report: Women have fewer procedures after heart attack than men
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.
Vaginal ring shields some women from HIV in NIH-backed study
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.
European Commission Pushes for Closer Convergence With US on Device Regulations
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.
FDA to Restrict Compounders from Making Copies of Commercially Available Drugs
The US Food and Drug Administration (FDA) in July 2016 issued two draft guidance documents describing how the agency will restrict the compounding of drugs that are essentially copies of commercially available or approved drugs.
Swiss scientists roll out low-cost portable diagnostic for Ebola
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.
Nature Biotech: Researchers 3-D print functional ear, bone and muscle structures
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.