Device Debuts: Tryton, Myriad Genetics, Integra Lifesciences, Acelity, And Toyota
This edition of device debuts highlights a wide variety of innovative devices introduced into commercial markets since the beginning of March, including a new stent for side-branch coronary interventions, an assay that identifies which breast-cancer patients do not need chemotherapy, a full ankle prosthesis, improvements to a negative-pressure wound therapy system, and a robotic system that helps paralyzed people learn to walk again.
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Myriad Genetics, Lumicell, and Agendia were among the companies with diagnostic technologies featured in the scientific presentations at the recent San Antonio Breast Cancer Symposium. New trials show that Myriad's EndoPredict can help identify patients who should not have preoperative chemotherapy. New Phase II data support Lumicell's LUM system for guiding excision of residual tumor and preventing cancer recurrence. Agendia's MammaPrint test proved cost-effective in the MINDACT trial.
Integra LifeSciences surged to industry-leading 12% sales growth in 2016, and that's before it prepares to consolidate two of the biggest acquisitions in its history. What is the strategy behind the success of the specialty surgery, orthopedics and tissue tech company that is looking at another double-digit sales uplift in 2017?
FDA's increasingly popular de novo classification pathway for moderate-risk devices that have no predicate accounted for five marketing go-aheads last month, four of which were for in vitro diagnostics.