Massachusetts Institute of Technology (MIT) and Boston Children’s Hospital researchers have discovered a way to prevent fibrosis from forming around medical device implants by blocking certain cells. The body’s immune system usually attacks implanted medical devices that are used for drug delivery, sensing or tissue regeneration. Defense cells in the body try to isolate the […]
These tiny jet engines could propel pharmaceuticals in the body
Researchers at the Max Planck Institute for Intelligent Systems in Stuttgart, Germany are creating nanorobot propulsion systems that could help transport pharmaceutical agents in the body. Two types of propulsion systems were created. One was powered by bubbles that are oscillated by ultrasound, while the other one was powered by an enzymatic reaction that would […]
Malaysia plans to ratify ASEAN Medical Device Directive
By Stewart Eisenhart, Emergo Group Malaysia’s medical device market regulatory agency has provided updates on various fronts at a recent seminar attended by Emergo consultants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or […]
Medtech stories we missed this week: March 17, 2017
The FDA awarded 510(k) clearance to a couple of medtech companies this week while others received tax breaks and incentives, including a local tax break for a $154 million Stryker R&D facility planned in Michigan. Here are some medtech stories we missed this week but thought were worth mentioning. 1. FirstRay wins FDA 510(k) clearance […]
510(k) submissions to FDA declining
By Stewart Eisenhart, Emergo Group The number of US-based medical device manufacturers submitting 510(k) premarket notification applications to the Food and Drug Administration has decreased over the past four years, according to a new Emergo study, while applications from European and Asian firms have increased. Get the full story here at the Emergo Group’s blog. […]
FDA proposes exempting 337 Class II devices from 510(k) requirements
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration (FDA) have proposed exempting hundreds of moderate-risk devices from 510(k) premarket notification requirements as the agency begins implementing components of the 21st Century Cures Act passed in late 2016. Get the full story here at the Emergo Group’s blog. The […]
No management support is common QMS audit problem
By Stewart Eisenhart, Emergo Group Undergoing an audit from a third party or conducting your own inspection of your medical device quality management system (QMS) can be a complex process with many moving parts—any of which can go wrong if not carefully monitored. Over a series of blog posts, we’ll discuss various common problems that […]
This uterine fibroid treatment is underused despite being cost-effective
A new study suggests that a minimally invasive, image-guided treatment for uterine fibroids is used a lot less than other surgical treatments. Hysterectomies were performed 65 times more than the minimally invasive uterine fibroid embolization (UFE), which has even been proven to cost less and result in a shorter hospital stay. “These findings suggest there […]
Minimally-invasive migraine treatment for adults works on kids, too
Migraine treatment that has been safe for adults has recently proven to be safe for use in children as well. The minimally-invasive treatment only takes a few minutes for children and teenagers to be able to feel the effects. The treatment involves a sphenopalatine ganglion (SPG) block that does not need needles. It uses a […]
Medtech stores we missed this week: March 10, 2017
The FDA and Health Canada cleared a couple medical devices while other companies touted their device studies. Here are medtech stories we missed this week but were still worth mentioning. 1. FDA clears Medela’s neonatal enteral feeding device Medela has received 510(k) clearance from the FDA to market its ENFit Low Dose Tip eternal syringes, […]