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What Is Medical 3D Printing—and How Is it Regulated?

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Advances in 3D printing, also called additive manufacturing, are capturing attention in the health care field because of their potential to improve treatment for certain medical conditions.

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A radiologist, for instance, might create an exact replica of a patient’s spine to help plan a surgery; a dentist could scan a broken tooth to make a crown that fits precisely into the patient’s mouth. In both instances, the doctors can use 3D printing to make products that specifically match a patient’s anatomy. And the technology is not limited to planning surgeries or producing customized dental restorations such as crowns; 3D printing has enabled the production of customized prosthetic limbs, cranial implants, or orthopedic implants such as hips and knees.

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At the same time, its potential to change the manufacturing of medical products—particularly high-risk devices such as implants—could affect patient safety, creating new challenges for Food and Drug […]

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