Learn about the new subclass for Class I reusable devices under MDR and the necessary steps to ensure compliance.
The new pump allows patients to customize their diabetes management.
If you’re looking to market your medical device, there are many tasks to complete.
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.