The US FDA has granted Investigational Device Exemption to Colorado life sciences company ZimVie for its cervical disc implant. The approval means the company can begin enrolling patients in a study to further evaluate the device.
ZimVie announced today that the US Food and Drug Administration has granted Investigational Device Exemption (IDE) for its Mobi-CCervical Disc, which is approved to treat more than one level of the spine.
The IDE approval means ZimVie can begin enrolling participants in a hybrid study following patients who receive simultaneous cervical disc...
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
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.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
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Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
