U.S. medical device industry representatives, for now, appear to be taking a wait and see approach as President Donald Trump’s administration wrangles over trade policy and threatens tariffs against China. The status of China tariffs on medical devices is unknown at this time as the Trump administration continues to make changes to its trade policies […]
FDA takes cautious approach to new regulations for OEM and third-party device servicers
By Joel Domanowski, Emergo Group The US Food and Drug Administration has cited insufficient evidence regarding public health concerns to warrant new regulatory requirements for original equipment manufacturers (OEM) and third-party servicers of medical devices, but will take less formal steps to ensure safety and effectiveness of these entities’ products and services. Get the full […]
7 medtech stories we missed this week: May 25, 2018
From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance […]
This tattoo-like sensor measures blood glucose levels non-invasively
Diabetes tracking can be a scary and tedious task, but University of California at San Diego researchers have developed a needless glucose monitor tattoo sensor that measures insulin levels through sweat on the skin. There are approximately 30.3 million people living with diabetes in the U.S., according to the American Diabetes Association. Monitoring blood sugar […]
8 companies commercializing transcatheter mitral valve replacements
Transcatheter mitral valve replacement is a new frontier in the cardio device field, with big legacy medical device companies including Edwards Lifesciences, Medtronic and Abbott spending hundreds of millions of dollars on companies in the space. Much different from transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement (TMVR) has been mostly experimental. TMVR is used […]
How an electronic Trial Master File review works
Rachel Silver-Kessler, director of clinical support services, IMARC You may already know all the documents that your Trial Master File should contain to tell the right story about your study. (Check out our infographic for guidance.) And you can probably guess that a remote audit of your electronic Trial Master File could provide significant savings […]
Medtech Association to host inaugural MedTechIDEAS Summit
The Medtech Association is hosting its inaugural MedTechIDEAS Summit on May 31 in Skaneateles Falls, N.Y. The event will take place at 11 a.m. until 5:30 p.m. at the Lodge at Welch Allyn. The MedTechIDEAS Summit is a quarterly conference series that presents a “big idea” in healthcare from an industry thought leaders while delivering competence-focused […]
What is the true cost of a Trial Master File review?
Sandra Maddock, CEO and president, IMARC Research Anyone who’s ever prepared for an FDA Inspection of their clinical study has undoubtedly spent hundreds of hours sifting through all of the essential study documentation that makes up the Trial Master File (TMF) in an effort to make sure every single document needed to tell the study’s “story” […]
FDA is asking for more information on application forms: Here’s why that’s good for innovation and improving health
By: Dr. Christopher Leptak To be most effective, electronic health records (EHRs) use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care. This helps to ensure consistency from EHR to EHR and allows these records to be usable from healthcare entity to health care entity, a concept […]
Stryker, J&J and Abbott ranked as top companies to work at in the U.S.
Stryker, Johnson & Johnson and Abbott have been named as some of LinkedIn’s top companies to work at in 2018. This marks the third year of “LinkedIn’s Top Companies 2018: Where the U.S. wants to work now,” which names the companies that professionals most want to work at based on a set of data points collected […]
7 exhibitors at DeviceTalks Minnesota you should know
DeviceTalks Minnesota is an annual event that allows some of the best minds in medtech to exchange ideas, insights and technologies. Medical Design & Outsourcing’s parent company WTWH Media holds DeviceTalks annually in Boston, Orange County, Calif., and the Twin Cities in Minnesota. It is hosted by MassDevice and attendees can plan to enjoy networking with people […]