Teleflex Says FDA Granted Breakthrough Designation to Freesolve Scaffold
Teleflex said the FDA granted Breakthrough Device Designation to its Freesolve resorbable magnesium scaffold for percutaneous coronary intervention.
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10:45:42 AM UTC
SquawkNews
Teleflex received FDA Breakthrough Device Designation for its Freesolve Resorbable Magnesium Scaffold for PCI, supporting accelerated development and review alongside the ongoing BIOMAG-III pivotal trial for a future PMA.Material DetailsContext by AI AnalystThis is an early regulatory milestone in…