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Home » Topics » Medical devices and technologies

Medical devices and technologies
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NIH-backed Medicasafe aims for FDA clearance of opioid use disorder drug-device combo

Nov. 13, 2019
By Stacy Lawrence
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.
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Emulate Liver-Chip bests animal models in predicting toxicity in 8 drugs

Nov. 8, 2019
By Stacy Lawrence
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.
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FDA authorizes first NGS test to detect critical HIV-1 drug resistance mutations

Nov. 7, 2019
By Meg Bryant
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).
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Dominican Republic expands its med-tech manufacturing exports

Oct. 23, 2019
By Sergio Held
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.
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Microlight3D awarded grant to develop 3D printer for dermal tissue regeneration

Oct. 2, 2019
By Bernard Banga
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.
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Investigator-led study finds BSX's Acurate Neo not noninferior vs. Edwards' Sapien 3

Sep. 30, 2019
By Stacy Lawrence
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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Medtronic gets greenlight for Intrepid TMVR study with transfemoral approach

Sep. 30, 2019
By Meg Bryant

Ancora Heart sees positive early results with Accucinch in systolic heart failure

Sep. 30, 2019
By Liz Hollis

Combo product reporting final retains 'similar product' language found in draft

July 26, 2019
By Mark McCarty
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.
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