Asthma Signals

May 22, 2017

FDA and NIH launch new clinical trial protocol writing tool By Stewart Eisenhart, Emergo Group US regulators at the Food and Drug Administration and the National Institutes of Health (NIH) have published a new writing tool for use in applying for regulatory approval to conduct clinical trials for medical devices and pharmaceuticals. Get the full story here at the Emergo Group’s blog. The opinions expressed […] 5 officials running healthcare under Trump President Donald Trump’s critics complain that the president has yet to make hundreds of appointments to midlevel positions. But at least with healthcare, we’re starting to get a clearer picture of who is in charge. Just on May 10, the U.S. Senate confirmed Dr. Scott Gottlieb as FDA commissioner. Here are 5 top officials shaping […] Gut microbiomes can predict non-alcoholic fatty liver disease There is a microbe in stool samples that can predict non-alcoholic fatty liver disease (NAFLD), according to researchers at the University of California San Diego School of Medicine. NAFLD occurs when there is a build up extra fat in liver cells that isn’t caused by alcohol, according to the American Liver Foundation. The liver has […] Why adding device identifiers to insurance claims protects patients The pushback to adopting unique device identifier into claims forms is that the added steps will be burdensome for hospitals. But documenting device identifiers in claims forms is actually “feasible” and “straightforward,” and requires only modest effort, according to a new whitepaper from Boston’s Brigham and Women’s Hospital. Of particular concern was that the device claims […] The key components of a well-designed wearable: Sense, analyze, act One of the earliest uses of a wearable technology was recorded during Emperor Nero’s rule over the Roman Empire from 54 to 68 AD. A brutal leader, the emperor enjoyed watching his gladiators fight  in crowded stadiums. As Nero watched his fighters battle, he was confronted with a problem – the glaring sun made it difficult […] Medtech stories we missed this week: May 19, 2017 From FDA clearances to touting study data, here are some medtech stories we missed this week but thought were still worth mentioning. 1. XpandOrtho wins FDA 510(k) clearance XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. The […] 10 innovative diagnostic tests to combat diseases This is an exciting time for medical diagnostics, with recent innovations allowing for faster disease diagnosis than ever before. From cancer to diabetes to heart disease, here are 10 diagnostic tests that could change the game when it comes to catching diseases earlier. Next >> [Want to stay more on top of MDO content? Subscribe to our […] FDA proposes Conformity Assessment pilot By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have begun seeking stakeholder feedback for a proposed system to better evaluate registrants’ compliance with voluntary consensus standards. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […] How to integrate usability throughout the design lifecycle Sarah Blair, Minnetronix The task of creating safe and reliable medical devices is the primary responsibility of medical device designers. Judgment must be used in assessing technology, diligence practiced in evaluating customer wants and needs, and completeness achieved in the execution of designs and processes. Integrating usability throughout the design lifecycle can greatly facilitate a […] Stem cells and graphene can regenerate nerves: Here’s how Iowa State University researchers have developed a nanotechnology that turns mesenchymal stem cells into Schwann cells for nerve regeneration. Schwann cells form sheaths around axons on nerves and promote regeneration of axons. They also produce substances that help promote the health of nerve cells. Both actions are helpful for researchers who are looking to regenerate […] Ambionics creates 3D printed prosthetic arm for infants Using Stratasys’ PolyJet 3D printing technology, prosthetic solutions company Ambionics was able to create a fully-functional 3D printed hydraulic prosthetic arm for an infant. The prosthetic was designed for Ambionics’ founder Ben Ryan’s 2-year-old son, enabling a more natural acceptance of prosthetics for children. So far, the 3D-printed hydraulic prosthetic has delivered 76% cost savings […] Leave a Reply You must be logged in to post a comment. Need Medtech news in a minute? We Deliver! MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today. Upcoming Events