With the launch of the National Medical Device Postmarket Surveillance System still years away, manufacturers should focus on the quality of their clinical trial data to increase adoption.
A new guidance document, “Patient Preference Information –Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling,” aims to allow patient perspectives to play a greater role in the regulatory process.
For the first time the orthopedic stem cell market was the fastest growing orthopedic biomaterial segment.
The site was a joint effort between the FDA, the National Institutes of Health (NIH) and the National Library of Medicine (NLM).
Serving a more cost-conscious group of providers has impacted the device design process in many ways.
According to a a study published in the journal in the journal Stem Cells Translational Medicine, researchers may have found a new protocol to grow and transform human embryonic stem cells into cartilage cells.
A team of researchers have developed a means of producing strong and durable bio-based polyurethane that could help contain costs and improve device function.
There are at least two efforts underway that could eventually serve as a substitute for the human meniscus.
Recently, an executive of medical device manufacturer B. Braun Medical Inc. made the case for the tax’s repeal at a Senate Finance Committee (Subcommittee on Health Care) hearing.
The 21st Century Cures Act aims to make a number of significant changes to the design and regulation of medical device clinical trials.
Leadless pacemakers represent an exciting new frontier for cardiac devices.
Knowing the most effective arthritis procedures favored by surgeons can help novel devices find a welcome market reception.
