The goal of the TAP Pilot is to reduce the time from concept to commercialization of medical devices by facilitating robust engagement early in the process with the FDA, industry and key stakeholders.
The key priority for any healthcare system should be the well-being of patients. At present, the U.S. healthcare system is failing to target low-hanging fruit that could help drive better results for patients, and—by catching illnesses earlier—ultimately lower the cost of our healthcare system.
There is capital sitting on the sidelines, but founders and CEOs should realize that investors are digging into their due diligence. The “wow” factor and potential size of the medtech market matter much less now than solid fundamentals.
“Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities” offers key recommendations for device manufacturers and developers on steps they can take to increase diversity in clinical research and address health equity.
Top reasons for recalls include software, quality and parts issues.
The challenge for the digital health community will be to bring the same high standards for care in the physical world to their digital interactions.
A review of new, successful treatment options for the novel coronavirus.
The absence of any of these disciplines can lead to blind spots that can introduce risk, but they are not all created equal.
No longer just “the big company advantage,” CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.
Lucira Health’s single-use molecular test kit will be available for prescription home use in people age 14 and older.