CHARLESTON VA 3D Innovation Center applies for FDA approval of its 3D printing medical equipment

China3D printingNet, April 12, the Ralph H. Johnson VA Medical Center, headquartered in Charleston, South Carolina, is3D printingHearing aids seek approval from the U.S. Food and Drug Administration (FDA).
According to “Live 5 News”, the center believes that once it succeeds, it will be able to use its 17 stations.3D printingThe machine produces thousands of medical equipment every year.The hospital is also the first in the United States to apply for approval from the FDA asVeterans Affairs (VA) Hospital3D printingHearing aidInstitutions.

Once approved, Charleston Virginia hopes to begin distributing more medical equipment in the next six months, and hearing aids alone can help approximately 8,000 hearing-impaired veterans.


3D printing
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3D printing

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3D printingMy earplugs can help protect the soldiers, who are often surrounded by my noisy machinery and weapons. The picture comes from the U.S. Army.

3D Innovation Center in Charleston, Virginia

The 3D Innovation Center in Charleston VA began printing masks and masks at the beginning of the Covid-19 pandemic, when medical needs were high.
At the time, Nikki Beitenman, a biomedical engineer located in the center, said: “The first thing we started printing was masks because of the shortage of manpower across the country. When we first tried to order from a supplier, we gave each mask a price of $4. . We can make them internally for a price of about 85 cents.”

In addition to providing its employees3D printingIn addition to custom masks, the technology is also used to produce optometry equipment for inspections, educational models for staff training, and connectable screens for swabs for Covid-19 testing.Ventilator dispensers, wheelchair accessories and patient-specific assistive devices also use 17 of the center3D printingMachine for additive manufacturing.
According to Bietenman, compared to purchasing products through suppliers,3D printingIt is critical to the hospital’s ability to quickly produce low-cost medical equipment for its patients.


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Produced on Stratasys J7503D printingOrthodontic model. Photos taken by Bone 3D.


3D printingMedical equipment

Charleston VA sought FDA approval for a hearing aid designed specifically for a local veteran. The team at the 3D Innovation Center can3D printingCustom-designed equipment to meet the unique needs of patients.
Once the FDA approves the device, the center hopes to expand the technology and provide more patients with personalized hearing aids when needed.The center can also carry out3D printingDentures, crowns and bridges, and various anatomical models, these models are much faster than what can be achieved by traditional manufacturing methods, and the cost is much lower.
Once approved by the FDA, the hospital plans to distribute more medical devices in the next few months and eventually hopes to produce thousands of medical devices every year.


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3D printingGuide to Titanium Surgery. Image taken by 3D Systems.

3D printingMedical device approval

With the development of standards and the advancement of technical capabilities, the development of medical equipment in recent years3D printingAccelerated.Although it continues to ask for clarification of its regulations,3D printingThe emergence of medical equipment has brought innovation, speed and cost advantages to the industry.
For example, in the past few years,3D printingBiopolymer bone implants, maxillofacial surgical guides, tooth aligners, and even patient-specific airway stents have all received FDA approval.In view of the pandemic, the FDA has updated the relevant3D printingFrequently asked questions about nasal swabs and other Covid-19 testing equipment.

FDA also approved for manufacturing3D printingMedical equipment3D printingSoftware Products. In 2019, Materialise’s Mimics Enlight 3D modeling software, together with 3D Systems’ orthopedic surgery virtual surgery planning platform, obtained the FDA-approved cardiovascular surgery plan. A study by the Central Hospital of the University of Bordeaux showed that, on average,3D printingThe model helps to increase the patient’s knowledge of their surgery by up to 50%.

(Editor in charge: admin)