Guidant Ancure Adverse Event Reporting Is Focus Of DoJ/FDA Probe
Guidant's disclosure of a criminal investigation by the Department of Justice and FDA related to the Ancure abdominal aortic aneurysm endovascular graft comes just one week after the firm highlighted Cook's Zenith AAA device as a key driver of the $3 bil. merger deal
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A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
CMS is proposing to classify all CGMs and insulin pumps as “items requiring frequent and substantial servicing” to expand device choice and access for Medicare beneficiaries. Under this framework, CMS also intends to move Class II devices, which include CGMs from Abbott and Dexcom and pumps from Tan
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.