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Conventus Orthopaedics wins FDA clearance for shoulder fracture fixation device

April 16, 2015 by Val Kennedy

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.

Coventus Orthopaedics

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.

EXCLUSIVE: FDA says ReShape Medical can skip advisory panel for obesity balloon device

April 7, 2015 by Brian Johnson

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.