MedTech News
Apiject Submits Innovative Prefilled Single Dose Injection Device for FDA Approval
STAMFORD, Conn., Sept. 25, 2025 /PRNewswire/ — Today Apiject Systems, Corp. (Apiject, www.apiject.com) announced its submission for regulatory approval of its New Drug Application (NDA) to the Food and Drug Administration (FDA) for the world’s first injectable medicine to use Apiject’s single dose, single use prefilled plastic syringe.
Tiny treatment system helps fight back against neuroinflammation in the brain
Neuroinflammation is linked to a host of detrimental brain disorders, including Alzheimer’s and Parkinson’s disease. A collaborative research team from Houston Methodist and Rice University has developed a way to fight back with a tiny, bioengineered system to deliver anti-inflammatory proteins to specific targets in the brain.
Robotic exoskeleton uses AI to ease walking for stroke survivors
For many stroke survivors, even the smallest number of steps carries enormous weight. Each movement becomes a reminder of lost coordination, muscle weakness, and physical vulnerability.
Machine learning and cell imaging combine to predict effectiveness of multiple sclerosis medication
Brazilian researchers, in partnership with French institutions, have developed a tool that can predict how patients will respond to natalizumab, one of the most commonly used drugs for treating multiple sclerosis.
Brain imaging method reveals hidden vascular changes with aging
Researchers at the Mark and Mary Stevens Neuroimaging and Informatics Institute (Stevens INI) at the Keck School of Medicine of USC have developed a brain imaging technique that reveals how tiny blood vessels in the brain pulse with each heartbeat—changes that may hold clues to aging and diseases such as Alzheimer’s.
New AI system could accelerate clinical research
By enabling rapid annotation of areas of interest in medical images, the tool can help scientists study new treatments or map disease progression.
Heartflow receives FDA clearance for updated plaque analysis platform
The updated algorithm shows a 21% improvement in plaque detection, compared to the original version.
Biolinq wins FDA de novo nod for autonomous, needle-free CGM
Biolinq announced today that it received FDA de novo clearance for its lead product, the Biolinq Shine wearable biosensor.