Literature DB >> 30282697

Regulating 3D-printed medical products.

Laura M Ricles1,2, James C Coburn3, Matthew Di Prima3, Steven S Oh4.   

Abstract

Additive manufacturing [also known as three-dimensional (3D) printing] is the layer-wise deposition of material to produce a 3D object. This rapidly emerging technology has the potential to produce new medical products with unprecedented structural and functional designs. Here, we describe the U.S. regulatory landscape of additive manufactured (3D-printed) medical devices and biologics and highlight key challenges and considerations.
Copyright © 2018 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.

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Year:  2018        PMID： 30282697     DOI： 10.1126/scitranslmed.aan6521

Source DB:  PubMed          Journal:  Sci Transl Med        ISSN： 1946-6234            Impact factor:   17.956


  14 in total

Review 1.  Antibiotics in 3D-printed implants, instruments and materials: benefits, challenges and future directions.

Authors:  David H Ballard; Karthik Tappa; Christen J Boyer; Udayabhanu Jammalamadaka; Kavya Hemmanur; Jeffery A Weisman; Jonathan S Alexander; David K Mills; Pamela K Woodard
Journal:  J 3D Print Med       Date:  2019-05-31

2.  Outcomes of Surgical Reconstruction Using Custom 3D-Printed Porous Titanium Implants for Critical-Sized Bone Defects of the Foot and Ankle.

Authors:  Bijan Abar; Nicholas Kwon; Nicholas B Allen; Trent Lau; Lindsey G Johnson; Ken Gall; Samuel B Adams
Journal:  Foot Ankle Int       Date:  2022-02-24       Impact factor: 3.569

Review 3.  Bringing hydrogel-based craniofacial therapies to the clinic.

Authors:  Alen Trubelja; F Kurtis Kasper; Mary C Farach-Carson; Daniel A Harrington
Journal:  Acta Biomater       Date:  2021-11-04       Impact factor: 10.633

Review 4.  Integrating Additive Manufacturing Techniques to Improve Cell-Based Implants for the Treatment of Type 1 Diabetes.

Authors:  Robert P Accolla; Amberlyn M Simmons; Cherie L Stabler
Journal:  Adv Healthc Mater       Date:  2022-04-22       Impact factor: 11.092

5.  Rheological and Mechanical Investigation into the Effect of Different Molecular Weight Poly(ethylene glycol)s on Polycaprolactone-Ciprofloxacin Filaments.

Authors:  Mohammed Elbadawi
Journal:  ACS Omega       Date:  2019-03-18

6.  Challenges of 3D printing technology for manufacturing biomedical products: A case study of Malaysian manufacturing firms.

Authors:  N Shahrubudin; P Koshy; J Alipal; M H A Kadir; T C Lee
Journal:  Heliyon       Date:  2020-04-12

7.  Intelligence-Based Spine Care Model: A New Era of Research and Clinical Decision-Making.

Authors:  G Michael Mallow; Zakariah K Siyaji; Fabio Galbusera; Alejandro A Espinoza-Orías; Morgan Giers; Hannah Lundberg; Christopher Ames; Jaro Karppinen; Philip K Louie; Frank M Phillips; Robin Pourzal; Joseph Schwab; Daniel M Sciubba; Jeffrey C Wang; Hans-Joachim Wilke; Frances M K Williams; Shoeb A Mohiuddin; Melvin C Makhni; Nicholas A Shepard; Howard S An; Dino Samartzis
Journal:  Global Spine J       Date:  2020-11-28

8.  Puncture and localization for percutaneous endoscopic lumbar discectomy with C-arm navigation: a randomized controlled cadaver trial.

Authors:  Hao Qin; Li Deng; Lin Xu; Qingchun Mu; Xiang Luo; Shengbin Huang; Maosheng Wang; Chunmei Luo; Chunming Huang; Wenhua Huang
Journal:  Ann Transl Med       Date:  2021-12

9.  Improving patient outcomes with regenerative medicine: How the Regenerative Medicine Manufacturing Society plans to move the needle forward in cell manufacturing, standards, 3D bioprinting, artificial intelligence-enabled automation, education, and training.

Authors:  Joshua Hunsberger; Carl Simon; Claudia Zylberberg; Preveen Ramamoorthy; Thomas Tubon; Ram Bedi; Kurt Gielen; Caitlin Hansen; Lynn Fischer; Jed Johnson; Priya Baraniak; Behzad Mahdavi; Taciana Pereira; Michael Hadjisavas; Shannon Eaker; Cameron Miller
Journal:  Stem Cells Transl Med       Date:  2020-03-28       Impact factor: 6.940

Review 10.  Recent Applications of Three Dimensional Printing in Cardiovascular Medicine.

Authors:  Chiara Gardin; Letizia Ferroni; Christian Latremouille; Juan Carlos Chachques; Dinko Mitrečić; Barbara Zavan
Journal:  Cells       Date:  2020-03-17       Impact factor: 6.600
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