dimecres, 23 de març del 2016

ACell wins 510(k) for modified MicroMatrix

ACellACell said today it won additional FDA 510(k) clearance for its MicroMatrix device allowing the use of the device in conjunction with Cytal wound matrix or Cytal burn matrix devices.

The MicroMatrix is a micronized particulate form of ACell’s Urinary Bladder Matrix designed to cover the wound bed in normal or irregular wounds, the Columbia, Md.-based company said.

“This is the 3rd major FDA clearance over the last year for ACell, and we have a pipeline of new regulatory and clinical applications planned, as we continue commercializing expanded uses of our UBM technology,” CEO Patrick McBrayer said in a press release.

The company said the clearance also allows for the modification of the MicroMatrix instructions for use to include the option to hydrate the device in sterile saline prior to application to allow for easier adherence to the wound bed.

The post ACell wins 510(k) for modified MicroMatrix appeared first on MassDevice.



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