The agency’s latest draft guidance is part of its strategy in creating a national evaluation system for medical devices.
A new treatment option is now available for patients who are candidates for an angioplasty and prefer an absorbable device to a permanent metallic stent.
Having the right internal material science expertise, along with aligning material specs with device outcomes is essential.
The cognitive app that aims to make daily diabetes management easier and more informative is in the final development stage.
A roundtable discussion on key issues that medtech companies face in product development.
Conducting usability tests will help manufacturers reduce the risk of harmful use errors and enhance device effectiveness.
Start-up Ariste Medical has developed technology to reduce surgical site infections and transform implants into combination products.
Although the U.S. Senate vote to appoint the new agency commissioner was overwhelming, it was not without critics.
The agency is creating a virtual center of excellence to expedite the development of combination products.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.