Pixee wins FDA nod for next-gen AR knee surgery tech
April 27, 2026
Pixee Medical announced today that it received FDA 510(k) clearance for its Knee+ NexSight augmented reality (AR)-based solution.
Pixee Medical announced today that it received FDA 510(k) clearance for its Knee+ NexSight augmented reality (AR)-based solution.
Vanderbilt researchers led by Xiaoguang Dong, assistant professor of mechanical engineering, have developed a novel device that can be used remotely to continuously monitor the airway stents of patients with diseases like lung cancer.
NEW YORK, April 27, 2026 /PRNewswire/ — TytoCare, a virtual care company enabling accessible, high-quality primary care from home, today announced it has received FDA De Novo classification for the first model of Tyto Insights™ for ENT Suite, marking the creation of a new regulatory category for AI-powered ENT image analysis.
The King’s College London team tested the wool-based keratin in animal models and found the material was able to guide new bone growth across damaged areas.
Medtronic (NYSE:MDT) today announced new milestones for its Affera family of technologies, including FDA breakthrough device designation.
BrioHealth announced that it received conditional FDA approval to conduct a clinical evaluation of its ventricular assist device (VAD) in pediatric patients.
In a study published in Biophotonics Discovery, researchers report a new way to examine white matter structure in postmortem human brains.
WEHI researchers have discovered a never-before-seen mechanism our bodies use to regulate sugar, in findings that rewrite the fundamental rules of biology and open a new frontier in science.
Lihong Wang, Bren Professor of Medical Engineering and Electrical Engineering, and a team of Caltech researchers have developed a system that can perform ultrasound tomography (UST) imaging on whole cross-sections of the body.
SEOUL, South Korea, April 24, 2026 /PRNewswire/ — CGBIO (CEO: Hyunseung Yu) announced that its patient-specific titanium implant, EASYMADE TI, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on April 9. The FDA 510(k) pathway is a premarket clearance process that demonstrates substantial equivalence to a legally marketed predicate device, allowing commercialization in the United States.