Abbott Wins FDA Clearance and CE Mark for Amplatzer Piccolo Delivery System for Premature Infants

Reuters12-18

Abbott Wins FDA Clearance and CE Mark for Amplatzer Piccolo Delivery System for Premature Infants

Abbott Laboratories has received U.S. Food and Drug Administration (FDA) clearance and CE Mark approval for its Amplatzer Piccolo™ Delivery System. This new system is designed specifically for use with the Amplatzer Piccolo Occluder to treat premature infants with a patent ductus arteriosus (PDA), a potentially life-threatening heart condition. The innovative delivery system enables more precise placement of the device in very small babies, simplifying the procedure and reducing risks for this vulnerable patient population. No other organizations are mentioned as recipients of this regulatory approval.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Abbott Laboratories published the original content used to generate this news brief via PR Newswire (Ref. ID: CG50320) on December 18, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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This new system is designed specifically for use with the Amplatzer Piccolo Occluder to treat premature infants with a patent ductus arteriosus (PDA), a potentially life-threatening heart condition. The innovative delivery system enables more precise placement of the device in very small babies, simplifying the procedure and reducing risks for this vulnerable patient population. No other organizations are mentioned as recipients of this regulatory approval.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Abbott Laboratories published the original content used to generate this news brief via PR Newswire (Ref. 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