Envoy Medical Submits First Module of Modular Premarket Approval Application to the U.S. Food and Drug Administration for Breakthrough-Designated Device
Envoy Medical submitted the first module of its Modular Premarket Approval application to the FDA for its Acclaim cochlear implant, a Breakthrough Device-designated product. The company expects to submit a total of four modules, with the final module containing clinical trial data targeted for the second quarter of 2027.
Key figures
- Drug Name
- Acclaim cochlear implant
- Phase Of Trial
- pivotal clinical trial
- Final module target
- Q2 2027
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