by Lauren Dubinsky
, Senior Reporter | March 28, 2018
Materialise became the first company to receive FDA clearance for the diagnostic use of 3-D printing anatomical model software last week.
“The FDA clearance for our Mimics inPrint software will support the adoption of 3-D planning and printing in U.S. hospitals and the creation of point-of-care 3-D printing facilities,” Wilfried Vancraen, CEO of Materialise, said in a statement.
The FDA stated in August 2017 that software “intended to create output files used for printing 3-D patient-specific anatomical models for diagnostic purposes” is considered a class II medical device and requires regulatory approval.
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The Mimics inPrint software is designed both for preoperative planning and to create physical models for diagnostic purposes such as patient management, treatment and communication between surgeons.
Hospitals across the U.S. are increasingly implementing 3-D printing practices as well as building point-of-care 3-D printing facilities. Sixteen of the top 20 hospitals — ranked by the US News and World Report — are leveraging Materisalise’s Mimics technology.
The 3-D printing medical device market is expected to grow from $713 million in 2017 to $3.5 billion in 2025, according to a Transparency Market Research report published in February.
The orthopedic, cranial implant and dental restoration implant segments accounted for more than 75 percent of the overall market in 2016. They are anticipated to remain at the forefront over the next few years.