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 […]
This brain-sensing headband gives scientists an idea of how brains age
A wireless brain-sensing headband is benefiting more than just the consumer. The valuable data that the headband creates and collects is shedding new light for neuroscience researchers on what happens to our brains as we age. Muse is a wearable device that helps users meditate. It guides the user through meditation by changing the sounds it […]
Chinese FDA updates recall process for medical devices
By Stewart Eisenhart, Emergo Group Medical device regulators at the China Food and Drug Administration (CFDA) have issued a new provision on its recall process for defective devices. 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 […]
7 medtech stories we missed: Feb. 10, 2017
From Glytec partnering to beat diabetes to Biolase, Gramercy Extremity Orthopedics and more getting FDA clearances, here are 7 recent medtech stories we missed this week, but were still worth mentioning. 1. BioTime proposes public offering of common stock Clinical-stage biotechnology company BioTech is intending to offer common stock shares in an underwritten public offering. […]
Missouri University researchers use autograft harvesting to treat chronic wounds
Chronic wound sufferers were able to get skin grafts in an outpatient clinic—all through a Missouri University research team’s work. The researchers used the Acelity Cellutome Epidermal Harvesting System. It is an automated, precise and reproducible process that offers minimal pain and less donor-site trauma. It features suction microsomes that harvest epidermal micrografts automatically, eliminating the […]
