January 11, 2018 “At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities,” said FDA Commissioner Scott Gottlieb, M.D. “By providing … Read more
January 09, 2018 The study, details of which were published in the Journal of the American Medical Association, looked at the 22 drugs that won accelerated approvals in 24 indications between 2009 and 2013. About two-thirds (2/3) of the trials that generated data to support these approvals lacked control arms, reflecting the FDA’s then-emerging willingness … Read more
January 04, 2018 The patches are made of heart tissues that are grown in a lab. One of the patches, which they call AngioChip, comes complete with blood vessels and heart cells that beat. And it is designed to be injected into the heart with a small needle. The researchers tested their patches in rats … Read more
January 02, 2018 Price, who has been looking for ways for the FDA to fight the opioid crisis, offered some hope for such treatment during a White House press session about the current situation. “One of the things they’re actually working on is a vaccine for addiction, which is an incredibly exciting prospect,” Price said referring … Read more
December 28, 2017 The first-of-its-kind study will consider cognitive assessments and survey responses as well as genetic data to learn how genes affect brain processes in people with major depressive or bipolar disorder, 23andMe said in a statement. Major depression is one of the most common mental health disorders in the U.S., affecting more than … Read more
Researchers at the École Polytechnique Fédérale de Lausanne’s (EPFL) Integrated Actuators Laboratory (LAI) have developed a small ring to be placed on the aorta to help those recovering from certain diseases or those waiting for a transplant. In those circumstances, the heart is often weakened and needs some help pumping.
December 27, 2017 The sales rep and physician study, now in its 15th year from DRG Digital’s Manhattan Research, found doctors say reps spend most of their time on material they already have or found on their own. And the “stale detail” is even worse in some specialty areas. Some 68% of the time pharma sales … Read more
December 21, 2017 The Nucleus 7 works natively with the iPhone. Users can go to the Accessibility settings of their device (locating in “Settings” then “General”) and pair it the same way you do a Bluetooth device. After that, the volume control on the iPhone will control the implant’s settings. You can do even more … Read more
December 19, 2017 While MRI scanners may be used to image newborns, transporting babies out of the NICU to the MRI can put them at risk, said Vasum Peiris, M.D., Chief Medical Officer for the Pediatrics and Special Populations at the FDA’s Center for Devices and Radiological Health (CDRH), in a statement. “Having a system … Read more
December 14, 2017 There is no single test for schizophrenia, so diagnosis typically involves observing symptoms and ruling out other potential causes for them, such as substance abuse or another mental health disorder. And while scientists have observed differences in brain scans of healthy people and those with schizophrenia; however, these are not currently used … Read more