FDA has about two or three months of device user fees as the backlog of unreviewed devices continues to grow.
Abbott CEO Miles White says the company is adding 300,000 new Freestyle Libre patients per quarter and growing. More than 1.3 million diabetes patients are currently using the device for continuous glucose monitoring.
Experts are using 3D scanning and 3D printing to craft patient-specific prosthetics and medical device implants with unprecedented precision.
Day Zero Diagnostics has raised $8.6 million to further develop a sequencing-based rapid diagnostic that identifies, within hours, both the species and the antibiotic resistance profile of a bacterial pathogen.
FDA took the next steps this week toward establishing the framework that is now being called the Safety and Performance Based Pathway. The agency also is seeking input from the industry on its plan to promote the use of more modern predicate devices in the 510(k) program.
Johnson & Johnson did improve performance in its medical device business last year, but CEO Alex Gorsky said the company has more work ahead to return to above-market growth in 2020.
The late-stage biopharmaceutical company is leveraging capital investment to advance its soft mist inhaled insulin product toward phase III trials and build a leadership team.
The Mountain View, CA-based company received a nod from FDA for the MUTYH-Associated Polyposis Genetic Health Risk report.
The donor-derived cell-free DNA test was developed by the National Institutes of Health/National Heart Blood and Lung Institute.
Prompted by a recent publication in the Journal of the American Heart Association that suggests a possible increased risk of death at two years and beyond in patients treated with vascular balloons coated with paclitaxel or stents that release paclitaxel, FDA said it is evaluating data and working directly with manufacturers to better understand this issue.
A student has won a global competition for her efforts to develop a synthetic material that could act as both a diagnostic and a therapeutic agent for bacterial toxins.
The Dublin-based company is launching a post-market study that will evaluate the use of the SynchroMed II intrathecal drug delivery system as an alternative to oral opioids.
The test, developed by Researchers at the Institute for Global Food Security at Queen’s University Belfast, can detect proteases, enzyme markers that are responsible for the progression of many diseases.
Focus on strategies that treat patients before they go on opioids, says a medical doctor and medtech innovator speaking in an upcoming MD&M West 2019 panel discussion.