MedTech News
Gene therapy may slow loss of motor function in ALS
Researchers have developed a gene therapy that significantly slowed motor function loss in preclinical models of amyotrophic lateral sclerosis (ALS), offering new hope for treating the devastating neurodegenerative disease.
Electrochemical catheter hub could prevent bloodstream infections
Washington State University and Mayo Clinic researchers have developed an electrochemical catheter hub that could someday help prevent deadly central line-associated bloodstream infections (CLABSIs) that annually kill thousands of people around the world.
AI-assisted model enhances low-quality MRI heart scans
An AI-assisted model developed by researchers from the University of Missouri School of Medicine and the School of Engineering can take low-quality MRI heart scans and turn them into high-quality images, while reducing the time needed to scan the heart by about 90%.
Sysmex America Receives FDA Clearance for Automated Blood Coagulation Analyzer CN-Series CN-6000™
CHICAGO, June 25, 2025 /PRNewswire/ — Sysmex America, Inc., a leading diagnostic solutions company offering hematology, hemostasis, urinalysis, flow cytometry and informatic solutions, has received FDA clearance for the CN-6000™ Automated Blood Coagulation Analyzer.
Tissum wins FDA nod for polymer platform for sutureless nerve repair
Tissium announced today that it received FDA de novo marketing authorization for Coaptium Connect with Tissium Light.
Vivasure submits PerQSeal for FDA approval, expands indications in Europe
Vivasure Medical announced today that it submitted its PerQSeal Elite vascular closure system to the FDA for premarket approval (PMA).
New point of care test to ‘revolutionise’ pre-eclampsia testing
A new point of care test for pre-eclampsia is set to revolutionise testing for suspected pre-eclampsia in maternity units across the UK, aiding early detection and prognosis in pregnant women between 20-37 weeks of gestation.
Nitinotes Announces FDA IDE Approval to Initiate Pivotal U.S. Trial of the EndoZip™ System for Endoscopic Sleeve Gastroplasty
CAESAREA, Israel, June 24, 2025 /PRNewswire/ — Nitinotes, developer of the EndoZip™ System, a fully automated suturing platform for endoscopic sleeve gastroplasty (ESG), today announced it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial under an Investigational Device Exemption (IDE).