By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration has indefinitely delayed implementation of part of a final rule covering intended use determinations by the agency following industry questions and concerns. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
Clinical support service pain points
John Lehmann, Director of Business Development for IMARC Research Outsourcing clinical support services is a common practice, but can be a challenging process. Over the years, we have had many conversations with sponsors regarding their need for clinical support services and they have shared many of the challenges they have faced. These concerns or pain […]
FDA announces deadline for UDI compliance for low-risk medical devices
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has formally pushed back some Unique Device Identification (UDI) compliance deadlines by two years for qualifying low-risk medical 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 […]
5 medtech stories we missed this week: Jan. 26, 2018
From Attune Medical receiving FDA 510(k) clearance to Synapse Medical having CE Mark approval, here are 5 medtech stories we missed this week but thought were still worth mentioning. 1. Attune Medical gets FDA 510(k) clearance Attune Medical announced in a Jan. 8 press release that it has received FDA 510(k) clearance for its EnsoETM […]
7 medtech stories we missed this week: Jan. 19, 2018
From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Privi Medical wins FDA nod for hemorrhoid device Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news […]
These medtech companies raised the most VC last year
Perhaps there’s a ray of hope that venture capital funding is recovering a bit for the medical device industry. VC firms invested more than $2.8 billion in 2017, an increase of more than $647 million from 2016, according to the MoneyTree Report from PricewaterhouseCoopers (PwC) and CB Insights. There were a total 229 deals involving […]
How blockchains could empower patients and secure data
Blockchains are best known as the technology behind cryptocurrencies such as Bitcoin Loophole Review. But the founders of a young Atlanta-based company called Patientory think they could have another important use – securing health data and empowering patients along the way. Secure access to patient data is a major issue for the healthcare industry. Patients […]
FDA to expedite release of recall information
By: Douglas Stearn, J.D. When FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant […]
Writing a monitoring report from beginning to end
John Lehmann, Director of Business Development at IMARC Research Writing great monitoring reports is not just about writing the report. It requires an in-depth knowledge of the job, the study protocol, the site, their practices, the sponsor’s procedures, the monitoring plan, the report template, and of course, the regulations. Attention to visit preparation, clear notetaking […]
3D printing and cryogenics could create new potential for artificial organs
Researchers at Imperial College London have developed a technique to replicate biological structures using cryogenics and 3D printing. The research is a first from the university to create structures that are soft enough to replicate the mechanical properties of organs like the brain and lungs. The 3D printing technique could create replica organs and assist […]
How medtech could stop the drug overdose crisis in the U.S.
The opioid epidemic is one of the deadliest problems facing the U.S. today. Through the development of new pain management devices, medtech could be a leader in solving the crisis. The prescription opioid overdose crisis in America didn’t start until the late 1990s, when pharmaceutical companies touted prescription painkillers that weren’t supposed to be addictive. […]