FDA Approves OSSDsign’s 3D Printed Cranial Implant

February 20, 2017 / by MedTech Momentum posted in 3D Printing, FDA approval, OSSDsign, PEEK

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The FDA has approved OSSDsign’s new cranial implant that uses an innovative and patented composite material printed to exact patient needs with a 3D printer.

The Uppsala, Sweden-based designer, manufacturer and distributor constructs individually designed and printed cranial implants using the patient's computer tomography (CT) information. The OssDsign system combines advanced computer-assisted design (CAD) with a proprietary calcium phosphate composite as a 3D printing material, which is reinforced by a titanium skeleton.

What You Missed Last Month (October 2015 – Medical Devices & 3D Printing)

November 13, 2015 / by Kapstone Medical posted in 3d print, 3D Printing, 3d prosthetics, 510(k), Additive Manufacturing, FDA, FDA 510(k), FDA approval, FDA clearance, innovators, inventors, kapstone medical, manufacturing, medical device, medical device inventors, medical devices, medtech, Monthly Round-Up, orthopaedic, Orthopedic, orthopedics, physician inventors, Product Development, surgeons, what you missed last month

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Happy November! Fall is finally here, and with the cascading leaves also descends a plethora of exciting developments emanating from the world of Medical Devices and 3D Printing!

What You Missed Last Month (August 2015 Edition –Medical Device & 3D Printing)

September 16, 2015 / by Kapstone Medical posted in 3d print, 3D Printing, 3d prosthetics, Additive Manufacturing, august, FDA, FDA 510(k), FDA approval, FDA clearance, first 3d printed pill, Intellectual Property, intellectual property strategy, jiminy, medical device, medical device inventors, medical devices, medtech, Monthly Round-Up, orthopediatrics, Orthopedic, orthopedic surgeons, orthopedic surgery, orthopedics, phototyping, physician inventors, Product Development, Regulatory, Regulatory affairs, spinal stenosis, what you missed last month

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It’s back to school with Team Kapstone! In August, we picked up educational and inspirational stories in 3D printing, medical device, and orthopedics. Here’s your August “What You Missed” reading list - three articles to Inspire, Equip, and Guide you through the last month:

What You Missed Last Month (May 2015 Edition- Medical Device & 3D Printing)

June 10, 2015 / by Kapstone Medical posted in 3D Printing, Additive Manufacturing, FDA, FDA approval, FDA clearance, innovators, intellectual property strategy, inventors, IP fit, IP services, kapstone, kapstone medical, kneeEOS, medical device, medical device inventors, medical devices, medical emergency, medtech, Model Prints, Monthly Round-Up, Orthopedic, orthopedic surgeons, orthopedic surgery, orthopedics, physician inventors, Product Development, prototyping, Radiography, Regulatory, Regulatory affairs, spinal fusion, titanium implant, TKA, what you missed last month

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Additive manufacturing, or 3D Printing, is dominating spring medical device industry headlines, and at halfway through the year, it’s slated to be on the Top 5 list of Kapstone Medical’s most inspiring and thought-provoking topics of 2015.

What You Missed Last Month (Apr 2015 Edition)

May 2, 2015 / by Kapstone Medical posted in 3D Printing, 3d prosthetics, 510(k), FDA, FDA 510(k), FDA approval, innovators, inventors, medical device, medical device inventors, medical devices, Monthly Round-Up, orthopedics, physician inventors, prosthetics, surgeons, what you missed last month

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It’s time to catch up, and Kapstone Medical is ready to equip and guide you through the month of April 2015 with some of the most interesting, engaging, and inspiring news from the FDA, biomedical, and 3D printing communities. Read on for what you may have missed last month:

4 Questions to Ask Before Submitting a 510(k)

March 5, 2015 / by Kapstone Medical posted in 510(k), FDA, FDA approval, innovators, kapstone medical, medical devices, physician inventors, product development advice, realize your idea, Regulatory, Regulatory affairs, surgeons

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So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA regulates medical devices, but that’s about as far as your knowledge takes you.

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