MedTech News
Natera introduces prenatal test for detecting inherited conditions
The introduction of the test is underpinned by data from the blinded, prospective EXPAND study, which began in 2023.
FDA Launches New PreCheck Program to Lower Regulatory Barriers to Pharma Manufacturing
Under PreCheck, the FDA will communicate more frequently with pharmaceutical companies, helping them as they establish or expand manufacturing sites in the U.S.
QinFlow Launches Advanced Fluid and Blood Warming Solution to Meet Critical Needs in ORs and ICUs
Founded in 2009, QinFlow is a market leader in fluid thermoregulation solutions.
Natural maple polyphenol found to inhibit tooth decay bacteria in new study
A new study in the journal Microbiology Spectrum highlights the potential of using a natural compound from maple to combat the bacteria responsible for tooth decay: Streptococcus mutans.
Full Market Launch of Cortium® Universal OCT Spinal Fixation System
PLANO, Texas, Aug. 7, 2025 /PRNewswire/ — ulrich medical USA, a leading medical device company focused on developing and commercializing spinal implant technologies, is proud to announce the full market launch of the Cortium® Universal OCT Spinal Fixation System, following a successful alpha release.
Instylla Gains U.S. FDA Premarket Approval for Embrace™ Hydrogel Embolic System
BEDFORD, Mass., Aug. 7, 2025 /PRNewswire/ — Instylla, Inc., a privately held company developing novel resorbable embolics for peripheral vascular embolization, announced premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the company’s flagship product Embrace™ Hydrogel Embolic System. Embrace HES has been approved for the embolization of hypervascular tumors in peripheral arteries ≤ 5mm.
China NMPA approves Bracco Imaging’s contrast agent for infertility diagnosis
The diagnostic performance of HyCoSy with SF6 microbubbles claims to have been validated by a meta-analysis of 24 trials.
First gene-edited islet transplant in a human passes functional trial
Uppsala University Hospital-led investigators report that gene-edited donor islet cells survived 12 weeks inside a man with long-standing type 1 diabetes without any immunosuppressive medication.