From 3M’s expanded 510(k) clearance for its Tegaderm dressing to Medtronic and Acacia burying the hatchet, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks Taiwanese distro deal for CGuard InspireMD announced in a June 8 press release that it has signed a distribution deal with […]
FDA changes medical device clinical trial IRB requirements
By Stewart Eisenhart, Emergo Group Medical device companies conducting certain types of clinical trials may now rely on central rather than local Institutional Review Boards (IRB) for reviews required by the US Food and Drug Administration. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
FDA extends UDI deadline for Class I devices
By Stewart Eisenhart, Emergo Group US Food and Drug Administration medical device regulators have extended Unique Device Identification (UDI) labeling and related compliance deadlines for lower-risk devices to late 2022 in order to fully standardize and optimize UDI data already collected on high-risk devices. Get the full story here at the Emergo Group’s blog. The […]
Australian regulators seek faster market access for device approvals overseas
By Stewart Eisenhart, Emergo Group Australia’s Therapeutic Goods Administration (TGA) has proposed allowing commercialization of medical devices that have already obtained approval from regulators in other markets without undergoing full premarket review. 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 […]
Medtech stories we missed this week: June 2, 2017
From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Dextera seeks expanded indications for MicroCutter 5/80 stapler Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The […]
Trump budget proposes $1B FDA user fee increase
By Stewart Eisenhart, Emergo Group The Trump Administration’s proposed 2018 federal budget would boost Food and Drug Administration user fees from medical device and drug registrants by more than $1 billion, in contrast to ongoing Congressional user fee negotiations that do not include such steep increases. Get the full story here at the Emergo Group’s […]
European MDR, IVDR officially entered into force
By Stewart Eisenhart, Emergo Group The May 26, 2017 date for official entry into force of new European medical device and IVD regulations has been reached, paving the way for full implementation of these regulations in 2020 and 2022. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
FDA cybersecurity workshop offers long-term solutions for medical device sector
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s latest workshop on medical device cybersecurity issues, held May 18 and 19, 2017, firmly established myriad challenges in mitigating this risk, and that no easy or quick fixes are yet available to help manufacturers and other stakeholders address these challenges. Get the full story […]
Medtech stories we missed this week: May 26, 2017
From Merck’s new licensing agreement to surgical study data being touted, here are medtech stories we missed this week but thought were still worth mentioning. 1. Merck inks exclusive licensing agreement for Alzheimer’s antibody Merck announced in a May 25 press release that it has entered an exclusive worldwide license agreement with Teijin Pharma. The […]
FDA Commissioner asks staff for ‘more forceful steps’ to stem the opioid crisis
By: Scott Gottlieb, M.D. As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases […]