The NeuroAccess technology employs focused ultrasound in combination with microbubbles to open the blood-brain barrier in a safe, temporary and noninvasive manner.
The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.
The Harmony Transcatheter Pulmonary Valve is an alternative to open heart surgery.
The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.