Stimatix GI gets FDA approval for low-profile colostomy device

Israel-based Stimatix GI has FDA clearance for its AOS-C2000 colostomy product line that provides voluntary bowel evacuation and improves the quality of life for people with a stoma. A CE mark application for Europe is also under review and expected shortly. The filing activities in Europe are to be followed by post marketing surveillance, aiming at product readiness to market in the EU by the end of the year.

Stimatix GI gets FDA approval for low-profile colostomy device

Israel-based Stimatix GI has FDA clearance for its AOS-C2000 colostomy product line that provides voluntary bowel evacuation and improves the quality of life for people with a stoma. A CE mark application for Europe is also under review and expected shortly. The filing activities in Europe are to be followed by post marketing surveillance, aiming at product readiness to market in the EU by the end of the year.

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