Cook Medical touts FDA win for next-gen colonic stent
Cook Medical won FDA clearance for the latest of its Evolution line, the Colonic Controlled-Release stent.
The device treats malignant neoplasms and large-bowel obstructions prior to colectomy procedures, offering greater control and maneuverability in the delivery process.
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BioMimetic launches pre-market approval bid for Augment bone graft
BioMimetic Therapeutics (NSDQ:BMTI) submitted a pre-market approval application for its Augment bone graft product, an alternative to autograft devices in performing hindfoot and ankle fusion procedures.
The Franklin, Tenn.-based device maker has braved a long road to the FDA, having in January cut 25% of its workforce as it faced delays in its PMA submission.
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Restoration Robotics announces CE Mark for Artas system
Mountain View, Calif.-based Restoration Robotics touted CE Mark approval in the European Union for its Artas system, a computer-assisted physician-driven platform for mapping and harvesting follicles from the scalp.
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