The new pump allows patients to customize their diabetes management.
The deal will help J&J speed up its entry into the robotics market.
The explosion of this technology is changing patient interaction with physicians, hospitals, and the entire healthcare landscape in general.
The deal will help strengthen the Edwards portfolio of smart monitoring technologies.
The agency’s intent is to decrease regulatory burden while promoting patient access to products.
Most devices are still developed in a moment of need and not in advance like adult devices.
The success of these technologies also relies on simplification to target certain patient populations, ensuring secure data transmission, and that operational models are built to make effective use of the data.
The device approvals address critical patient need.
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
Last year the agency surpassed a 40-year record set in 2017, approving 106 novel devices.