Category: Food & Drug Administration (FDA)
Ventripoint says won an expanded indication from the FDA for its VMS cardiac diagnostic device and is seeking to land a $700,000 private placement.
VertiFlex says it won pre-market approval from the FDA for its Superion interspinous spacer.
VertiFlex said today that it won pre-market approval from the FDA for its Superion interspinous spacer for treating moderate lumbar spinal stenosis.
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.