Another busy month has passed in the MedTech Industry; especially with 3D printing. From using custom 3D printed valve models for heart surgery to the FDA presenting its case for regulating 3D printed technology, lots of exciting things happened in the month of October. Here’s what you missed last month:
The US Food and Drug Administration (FDA) has recently presented its case for regulating 3D printed, patient-specific anatomical models as medical devices when they are marketed for diagnostic use. These models are being increasingly used by surgeons and physicians to help visualize and measure patient-specific anatomy to advise treatment decisions.
According to the FDA, these 3D printed models are made either by hospitals and clinics that use them, medical device manufacturers, or third-party service providers. FDA officials explained that the software that is used to generate these models would be considered a Class II medical device. While presenting their case for 3D printing regulations, the FDA explained who needs clearance and provided detailed information on the data requirements and guidance.
A new study aims to alert medical professionals of the potential of 3D printing’s future use. 3D printing technology is expected to transform medicine through patient-specific surgical models, custom-made
prosthetics, personalized on-demand medicines, and 3D printed human tissue.
Studies of surgeons using 3D printed models to rehearse procedures have shown that operations can be completed faster and with less trauma for patients. There are also potential cost savings to consider. 3D printing is said to be a “revolutionary technology” that will improve medical care.
Because of 3D printed models, the guessing game of where to put a stent during heart surgery may soon be over. Researchers from the Georgia Institute of Technology and the Piedmont Heart Institute have discovered a new way to develop heart valve models using a 3D printer.
By creating custom models, doctors can select the best size and model stent for a patient, cutting down the risk of side effects. These 3D printed models can also be used to help train surgeons.
Don’t miss out on anymore medical device and 3D printing technology news. Follow us on LinkedIn to always stay up-to-date and informed on what is going on in the MedTech Industry.