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.
Via partnerships with pharmaceutical companies, Insulet expands its platform technology past insulin delivery.
The rise in chronic disease and the effort to reduce healthcare costs presents a large opportunity for the field of regenerative medicine.
The company will invest €13 million in the facility, which will make drug-coated balloons for peripheral artery disease.
Researchers say the technology enables a high drug load and consistent drug release profile.
In lieu of trials, some companies may be able to submit a CER.
When preparing a regulatory submission, there are a couple of critical elements to consider.