BOGOTA, Colombia – The Latin American med-tech sector is moving steadily toward 3D printing solutions to speed up production and cut costs in specific sub-sectors, such as orthotic devices. A case in point is Prothesia, of Monterrey, Mexico.
Time will tell whether what the Trump administration is calling a “historic” and “landmark” trade agreement with China will better enable drug and device companies to more fairly compete in the Chinese market without having to sacrifice their intellectual property (IP) and technology.
The FDA's revised draft guidance for clinical decision support (CDS) systems was intended to fix several glaring holes in the first draft, but multiple stakeholders argued that the second draft contradicts the related provisions of the 21st Century Cures Act when it comes to CDS systems that purport to drive or guide clinical decision making.
Researchers are hopeful that within three to five years the first once-a-month oral contraceptive could reach human testing. They achieved an early step on that path with the publication of research testing the long-lasting drug delivery device from Watertown, Mass.-based startup Lyndra Therapeutics Inc. in the Dec. 4, 2019, issue of Science Translational Medicine.
Drug addiction has often proved resistant to the best efforts for treatment. New York-based startup Medicasafe Inc. hopes to provide another tool in the arsenal to boost opioid use disorder (OUD) treatment. Rather than send a recovering addict home every couple of weeks with an unmonitored and uncontrolled supply of buprenorphine and naloxone, it has developed a drug-device combination product that digitally enables and tracks patient retrieval of those drugs.
Preclinical animal and cellular models are notoriously bad at predicting drug candidate toxicity in humans. Animal biology is often fundamentally different on that front than in humans, while cells in the lab can't be counted on routinely to replicate the bodily response.
Singapore-based Vela Diagnostics Holding Pte. Ltd. has received U.S. FDA authorization via the de novo approval pathway for an in vitro diagnostic test to detect HIV-1 genomic drug resistance mutations (DRMs).
BOGOTA, Colombia – During the past few years, the Dominican Republic has become one of the leading medical device suppliers to the U.S. It has positioned itself as the Latin American country with the highest export value of medical and surgical instruments worldwide. This year, it aims to expand its med-tech exports at a 7% rate.
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.
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