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FDA Says A.D.A.M.’s 3D Printed Bones are Eligible for 510(k) Clearance

FDA Says A.D.A.M.’s 3D Printed Bones are Eligible for 510(k) Clearance

Written by David

October 13, 2020

As the healthcare industry increasingly welcomes and adopts the use of 3D printing, and other technology solutions such as AI and big data, it’s helping to improve some long-standing issues, including the demand for materials like organs and human tissue.

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Because of weak links in the supply chain (and the COVID-19 pandemic is shining an unflattering light on many supply chain vulnerabilities right now), for biomaterials like these, that need is often going unmet.

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But with help from 3D printing, researchers are now able to fabricate these materials in a laboratory setting, and Jordan Miller, assistant professor of bioengineering at Rice University and an expert on fibers and polymers, believes that we could even begin clinical trials for 3D printed replacement organs within the next five to ten years.

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However, a Connecticut-based 3D bioprinting company called A.D.A.M. (Advanced Development of Additive Manufacturing) thinks that, at least in […]

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