By Stewart Eisenhart, Emergo Group Effectiveness of ongoing efforts to address medical device cybersecurity risks will depend on whether stakeholders can properly balance security, safety and usability issues as well as understand end-user environments, according to speakers at a new US Food and Drug Administration workshop. Get the full story here at the Emergo Group’s […]
‘Radiating Shoe Sales’
By: Vanessa Burrows Since the discovery of X-rays in the late 19th century, the technology has enhanced health care in a variety of ways. Like many cutting-edge scientific developments, however, it also has inspired uses of uncertain therapeutic value. That was the case with the shoe-fitting fluoroscope, the subject of the latest episode of FDA’s […]
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 […]
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 […]
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 […]
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 >>
Dr. Gottlieb’s first remarks to FDA staff
Remarks by Scott Gottlieb, M.D. FDA All Hands Meeting May 15, 2017 Silver Spring, MD It’s an honor to be here today and to be taking on this responsibility with all of you. You realize how special our mission of consumer protection and public health promotion is when you explain what we do to the children […]
Engineered tissue could eliminate radiation for bone marrow transplants
University of California San Diego engineers have created artificial bone tissue that could eliminate the need for radiation before bone marrow transplants. Shyni Varghese, a bioengineering professor at UC San Diego Jacobs School of Engineering, led a team to develop a bone-like implant to eliminate the pre-treatment radiation that kills stem cells in a patient’s bone […]
China regulators formalize procedures for medical device expert panel meetings
By Stewart Eisenhart, Emergo Group Regulators at the China Food and Drug Administration (CFDA) have published formal procedures for expert panel meetings held to discuss medical device registration issues, clarifying the process for Chinese market applicants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Medtech stories we missed this week: May 12, 2017
From Bioness’s new distribution deal to InBrace’s launch of new braces technology, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Obalon receives approval to commercialize in Middle East Obalon Therapeutics announced in a May 11 press release that it has received regulatory approvals in select Middle East […]