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Cohera Medical’s Novel Sealant Picked For FDA 'Expedited Access'

FDA launched its new Expedited Access Pathway in April, and Cohera Medical is now the first company to announce participation for its Sylys Surgical Sealant. Under the program, Cohera hopes to use an interim trial analysis to accelerate the product's path to market.

Cohera Medical Inc. says its Sylys Surgical Sealant has been selected by CDRH for its new Expedited Access Pathway, offering the prospect of using an interim clinical trial analysis as a way to kick-start PMA review and approval for the device, among other benefits.

The EAP program was launched by FDA in April and Cohera appears to be the first to publicly announce its participation. The program is intended give select devices that address...

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