insights
It’s time to catch up, and Kapstone Medical is ready to equip and guide you through the month of April 2015 with some of the most interesting, engaging, and inspiring news from the FDA, biomedical, and 3D printing communities. Read on for what you may have missed last month:
Materialise World Conference 2015 and the Mimics Innovation Summit
The Materialise World Conference 2015 was held in Brussels, Belgium from April 23rd to April 24th, 2015, welcoming the world’s leading thinkers and doers in 3D printing. Kapstone Medical Founder and President John Kapitan spoke about “Utilizing Population-Based Data to Drive the Design of a Novel Shoulder Arthroplasty Implant” as part of the Mimics Innovation Summit, focused on the biomedical industry.
FDA Attempting to Simplify Process for Medical Device Makers to Use Foreign Clinical Trial Data
While many medical device trials occur outside the United States, it can be difficult to utilize the data within our borders because of regulatory inconsistencies with the FDA. An attempt to simplify the process begins with a new document outlining the standards the FDA expects from clinical studies outside the US to promote consistency in trial design while protecting trial subjects. While this document is only an indicator of what the FDA expects, and not a policy change, stay tuned for more developments on this subject.
New FDA Program to Expedite the Approval of Breakthrough Medical Devices
FDA has two new policies that will expedite access to potentially life-saving medical devices. Some medical devices can be approved with less data and a shorter timeline than ordinarily required with similar devices. Programs currently exist to expedite the approval of pharmaceuticals.
Limbitless Solutions Partners with University of Central Florida in Creating Prosthetic Limbs
As a follow up to our inspiring March story on a young boy’s new Iron Man-inspired prosthetic arm, the University of Central Florida announces it will partner with student-led, non-profit Limbitless Solutions to create a “worldwide resource for 3D printed biomedical solutions.
Medical Device Recalls Plunge to Near-Record Lows in First Quarter of 2015
Medical device recalls appear to have plunged in Q1 2015, as published by FDA’s year-old open data platform, openFDA. FDA has gone from record highs to near record lows on recalls in just a single quarter. First quarter 2015 closed at 426 recalls total.
It’s easy to catch up on last month’s medical device and 3D printing news with Kapstone Medical. Get a recap on March 2015 here.
