New York-based startup 3Dbio Therapeutics snagged a rare pediatric disease designation from the U.S. FDA for Aurinovo, its investigational combination product for reconstruction of the outer ear in patients with microtia. The product offers an alternative to established treatments, none of which enable patients to regain an auricle comprising living tissue other than rib grafts, which are associated with significant donor site morbidity.

PERTH, Australia – Industry was supportive of most of the changes proposed by Australia’s Therapeutic Goods Administration (TGA) for custom-made and 3D-printed devices. However, the comments also indicated that the current regulatory requirements for custom-made devices are not well understood. The agency stressed that increasing use of 3D printing for medical applications is raising questions about the adequacy of the current medical device regulatory framework to mitigate risks to patients.

PARIS – Microlight3D SAS, based in La Troche, France, is about to receive a $900,000 grant from the EU to develop new 3D printer technology dedicated to treating acute wounds and chronic ulcers that do not heal. "It's about developing a novel process based on ion-releasing biomaterials promoting angiogenesis for skin regeneration," Denis Barbier, optoelectronics laser specialist and CEO of Microlight3D, told BioWorld.

PARIS – Microlight3D SAS, based in La Troche, France, is about to receive a $900,000 grant from the EU to develop new 3D printer technology dedicated to treating acute wounds and chronic ulcers that do not heal. "It's about developing a novel process based on ion-releasing biomaterials promoting angiogenesis for skin regeneration," Denis Barbier, optoelectronics laser specialist and CEO of Microlight3D, told BioWorld MedTech.

Researchers from the Swiss École Polytechnique Fédérale de Lausanne (EPFL) and the University Medical Center Utrecht in the Netherlands have developed a bioprinting process that allows simultaneous production of the entire volume of complex shapes, providing much greater flexibility and faster production than layer-by-layer 3D printing. Details on the process, called volumetric printing, and printer were published in Advanced Materials.

It’s truly a futuristic world we live in with technology that not so long ago was only seen in science fiction. Last year, as part of a three-part series Medical Device Daily published, I explored 3-D printing and the potential for that technology, which enables us to make solid objects from...

Much to my father’s utter disappointment I’m sure, I did not inherit the sci-fi appreciation gene. I never understood the cult phenomenon created by Star Trek and have always preferred living in the now over fantasizing about the future. While I’ll never be able to call myself a Trekkie, I have slowly gained an appreciation over the years for technology that seems to have been plucked right off the fictional starship USS Enterprise. A fascinating example of this, as Spock would say, is the rise of 3-D printing. The advancement of 3-D printing, also known as additive manufacturing, is predicted...