Category: Food & Drug Administration (FDA)
Conventus Orthopaedics, with an FDA clearance in hand, plans a gradual rollout of a new device designed to help repair shoulder fractures in a less invasive way.
Conventus Orthopaedics gained FDA clearance for a device that helps repair shoulder fractures, and will pursue a "measured" U.S. market rollout in the weeks ahead, company officials said.
The FDA lets San Clemente, Calif.-based ReShape Medical skip an advisory committee meeting for its obesity balloon device, CEO Richard Thompson tells MassDevice.com.
ReShape Medical, which is developing a balloon system to combat obesity, notched a significant victory in its path to commercialization, CEO Richard Thompson told MassDevice.com today.
Regulators at the FDA waived a requirement that the San Clemente, Calif.-based company appear before an advisory committee for its premarket approval application, Thompson told us. That removes a significant amount of uncertainty from the arduous PMA process for the ReShape Duo device, he said.