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.

SAN FRANCISCO – As the transcatheter aortic valve replacement (TAVR) field matures, it is becoming increasingly difficult to develop a new implant that can distinguish itself vs. competitors. The incremental benefits are narrowing rapidly, making it tough to distinguish new iterations from one another using standard, randomized trials.

Device makers have reporting responsibilities for devices used in combination products per an FDA final rule published in 2016, but the FDA said in the 2018 draft guidance that the applicant of a drug- or biologic-led combo product must evaluate whether a malfunction of the device component would suggest a hazard for similar combinations using that device. That provision appears in the final rule, and thus puts the onus on makers of drugs and biologics to do a job device makers say is theirs to handle.