Orthopedic devices manufacturer is preparing 510(k) submissions for two constrained hip products, the ZCA "All-Poly" acetabular cup and Trilogy acetabular system constrained liner, following the recent downclassification of constrained hip liners from Class III to Class II (1"The Gray Sheet" May 6, 2002, p. 19). Announced by FDA April 30 and effective May 30, the final rule reclassifying of hip joint metal/polymer constrained cemented or uncemented prostheses has the effect of "potentially shortening the product review and approval cycle from years to months," Zimmer notes...
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HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
