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<nspnews type="text">
<version>v8.0</version>
<date>2026-04-22 18:02:54</date>
<action>I</action>
<registdate>2026-04-22 17:20:44</registdate>
<modifydate>2026-04-22 18:01:58</modifydate>
<publishdate>2026-04-22 18:02:46</publishdate>
<embargo>N</embargo>
<newsid>810565</newsid>
<orgid>810477</orgid>
<language>EN</language>
<category1>20</category1>
<category2>2001</category2>
<category1_name>기업</category1_name>
<category2_name>중기/벤처/기타</category2_name>
<statusID>1</statusID>
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<typeID>3</typeID>
<newsSubject><![CDATA[CGBio, Securing FDA Approval for Customized Implants]]></newsSubject>
<newsSummary><![CDATA[]]></newsSummary>
<newsTag><![CDATA[CGBio,FDAApproval,EASYMADETI]]></newsTag>
<newsLinks><![CDATA[]]></newsLinks>
<news_prolog><![CDATA[(Seoul=NSP NEWS) =]]></news_prolog>
<news1><![CDATA[CGBio has secured approval from the U.S. Food and Drug Administration(FDA) for its patient-customized titanium implants. With this approval, the company is set to target the U.S. market for skull and craniofacial reconstruction.

CGBio announced on the 22nd that its patient-customized titanium implant, 'EASYMADE TI', received FDA 510(k) approval on the 9th.

The FDA 510(k) is a representative pre-market approval procedure for medical devices sold in the United States. The company stated that this is the first time a domestic company has received FDA approval for a customized titanium implant for the U.S. market.

EASYMADE TI is a custom implant designed based on patient CT data. It is used for the reconstruction of the skull and non-weight-bearing craniofacial defects(parts of the facial bones that do not support body weight).

A CGBio official said, “The U.S. cranial implant market is expected to exceed $500 million in 2024,” adding, “An average annual growth rate of over 6% is projected from 2025 to 2034."]]></news1>
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<news_epilog_byline><![CDATA[By Soon-ki Lee(s8789@nspna.com) and Songyi Jeong(qu225577@nspna.com)]]></news_epilog_byline>
<news_epilog><![CDATA[ⓒNSP News Agency·NSP TV. All rights reserved.]]></news_epilog>
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<location><![CDATA[Seoul]]></location>
<teamID>110</teamID>
<teamName><![CDATA[국제부]]></teamName>
<writerID>s8789</writerID>
<writerName><![CDATA[Soon-ki Lee]]></writerName>
<writerTitle><![CDATA[Reporter]]></writerTitle>
<writerEmail><![CDATA[s8789@nspna.com]]></writerEmail>
<writerID2>qu225577</writerID2>
<writerName2><![CDATA[Songyi Jeong]]></writerName2>
<writerTitle2><![CDATA[Reporter]]></writerTitle2>
<writerEmail2><![CDATA[qu225577@nspna.com]]></writerEmail2>
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