The agreement will create a pure-play infusion therapy company.
Some insights on integrating stability testing requirements into a device organization’s plan to make combination products.
Highlights include leveraging big data, streamlining clinical trial design, reducing healthcare-associated infections and toughening up on cybersecurity.
In the medical device world, “sustainability” is more than a buzzword—it’s an economic and social duty.
The IN.PACT Admiral device will provide a new treatment option for PAD patients.
Human factors engineering and the tools companies can leverage will get way more sophisticated.
The process gives sponsors the ability to interact more with FDA.
The agency’s latest draft guidance is part of its strategy in creating a national evaluation system for medical devices.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.