By Stewart Eisenhart, Emergo Group One third of all medical device companies participating in a recent Emergo industry survey reported sales increases of 10% or more for 2016. 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 […]
Maintaining professionalism during a conflict
Lindsey R. Friedrich Maintaining professionalism in a difficult situation is, unfortunately, something most professionals encounter during their career. Being able to keep calm and stay logical during these times is key to maintaining trust with a client, and helping them feel comfortable and confident to work with you to resolve the issue(s) at hand. For […]
7 medtech stories we missed: Feb. 17, 2017
Several companies released diabetes study results this week, while companies like BioTime closed on their public offerings and Pixium implanted its first bionic eye. Here are 7 medtech stories we missed this week, but were still worth mentioning. 1. Insulet touts glucose control study Insulet Corp. announced the results from its first feasibility study of its Omnipod […]
Genetically engineered T-cells treat leukemia in babies
Researchers in London have successfully treated leukemia in two babies, in what they are touting as the world’s first treatment of cancer using genetically engineered immune cells from donors. Two British infants, who were 11 and 16 months old, were treated using Cellectis’ CAR T-cell product, UCART19, which is an allogeneic CAR T-cell product candidate […]
Chinese regulators modify IVD classification requirements
By Stewart Eisenhart, Emergo Group Regulators at the China Food and Drug Administration (CFDA) have issued a new order affecting how in vitro diagnostic (IVD) devices are classified according to risk levels. 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 […]
How a federal regulation is born
Regulations are a set of legal rules that are established by a regulatory authority such as the FDA. They are required to be followed and are enforceable by legal consequences such as fines or imprisonment. The process of making a regulation can be a lengthy but important process. Federal agency priorities, industry trends, public safety, […]
This tiny camera on a needle could enable safer brain surgeries
A team of researchers at the Center for Nanoscale BioPhotonics at the University of Adelaide in Australia have developed a brain biopsy needle with a tiny camera attached to the end to make brain surgery safer. When performing surgery on a brain tumor, regular biopsy needles usually pose the risk of hitting a blood vessel, […]
Are clinical vendor audits important?
In today’s business environment, it’s important to have reliable partners who can help you achieve your business goals and objectives. In clinical research, this is especially true. One proactive way to ensure your trial partners are meeting your standards is to conduct vendor audits. Clinical vendor audits assess the performance of the multi-faceted service delivery […]
These computers can identify diseases in your fecal matter
San Diego–area researchers have successfully trained computers to recognize whether microbiomes in the gut are healthy or unhealthy, based on their genetics. The research out of UC San Diego and the J. Craig Venter Institute (JCVI) offers promise for non-invasive diagnostic tools by taking the genetic sequencing of fecal samples as opposed to blood sampling. There are trillions […]
S&P: Medtech outlook stable, even after downgrades
The outlook for investment-grade medical device companies remains stable even after a 3-year streak of 9 consecutive downgrades, according to a new report from S&P. The downgrade of investment-grade medical device companies was mostly caused by debt-financed mergers and acquisitions, according to S&P. Factors like changes in operating performance trends and financial policy also contributed […]
Mexico proposes changes to medical device regulations in 2018
By Stewart Eisenhart, Emergo Group Mexican regulators are in the early stages of revising various elements of the country’s sanitary registration process for medical devices, including classification, biocompatibility and technovigilance. 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 […]
