December 2019 Approvals Snapshot: Abbott Earns New Approval For CentriMag Circulatory Support System

December’s new medical device approvals include the FDA approval of Abbott Laboratories’ CentriMag circulatory support system for postcardiotomy patients, MicroVention’s FRED system for wide-necked intracranial aneurysms and an expanded indication for Foundation Medicine’s FoundationOne CDx cancer-drug companion diagnostic.

Approved

The US Food and Drug Administration approved two original premarket approvals (PMA) and one panel-track PMA supplement in December 2019.

On 6 December, the agency approved a PMA for Abbott Laboratories Inc.’s CentriMag circulatory support system for patients...

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