Medical Design & Outsourcing has made an annual effort during “spooky season” to shed light on some early medical devices and innovations and the museums that hold them, but this year is a bit different. Last year, we visited the Earl Bakken Museum’s backroom to get a look at early medical devices. A few years ago, we […]
medical devices
Fibrosis: How to prevent it in medical device implants
Massachusetts Institute of Technology (MIT) and Boston Children’s Hospital researchers have discovered a way to prevent fibrosis from forming around medical device implants by blocking certain cells. The body’s immune system usually attacks implanted medical devices that are used for drug delivery, sensing or tissue regeneration. Defense cells in the body try to isolate the […]
FDA’s CDRH reveals guidance plans for FY2017
Heather Thompson, MDO senior editor CDRH is setting its goals along with the rest of us for the new year. The agency has published and prioritized its intentions for FY2017, starting with a list of new documents it intends to release in FY2017 (A-list). It has also shared a B-list of previously-issued final guidances for […]
Changing your medical device: What you need to know
When it comes to changing a medical device, one of the most important decisions can involve whether to log it in as an internal letter-to-file or submit a special 510(k) or PMA supplement with FDA. In many cases, company officials don’t do some initial investigation before making the decision, according to Vascular Sciences President Michael Drues, who has […]
FDA issues final guidance on ’emerging signals’
FDA will start issuing early warnings about medical devices that may be causing adverse events, under a final guidance for industry and FDA staff released this week. The plan for the agency to publicly disclose emerging safety signals drew fire from industry groups earlier this year. AdvaMed, for example, said in its public comment to […]