The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.
The hot issues are related to compliance, EU MDR and recalls.
Technology will continue to evolve to allow patients greater control over their healthcare.
The idea of harnessing the body’s response to heal and defend is no longer the stuff of science fiction.
With May 26, 2020 quickly approaching, every day counts.
The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.
Manufacturing microfluidic devices requires sophisticated techniques.
Expanded designs that enable clinicians to leverage data in making healthcare decisions, but privacy challenges remain.
Personalized medicine is the future of healthcare, and artificial intelligence will play a big role.
The goal of the voluntary program is to streamline the submission process. The agency also announced that it has selected participants for its EtO Innovation Challenges.