Articles related to MEDICAL DEVICES

The FDA cleared the Dexcom Stelo Glucose Biosensor System for over-the-counter use in children ages 2 and older who do not use insulin, expanding a device previously limited to adults and supporting caregiver-supervised home glucose monitoring.

An interventional cardiologist at UCLA Health describes how combined IVUS and near-infrared spectroscopy imaging identified culprit lesions in angiographically ambiguous NSTEMI cases and informed stent landing zone decisions in complex PCI.

A retrospective analysis of FDA postmarketing reports identified textural changes, pigmentary alteration, and subcutaneous fat loss as the most frequently reported adverse events following radiofrequency microneedling, with most cases occurring on the face and submental area.

The FDA granted 510(k) clearance for a wireless-enabled pressure-modulating goggle system designed to reduce nocturnal intraocular pressure in adults with open-angle glaucoma, with availability expected in Q4 2026.

Pediatric patients who started automated insulin delivery within 6 months of type 1 diabetes diagnosis had a median HbA1c of 7.1% at 24 months versus 9.8% in non-users in a US multicenter retrospective cohort.

Two retina specialists debated whether LIGHTSITE III evidence supports photobiomodulation as treatment for intermediate dry AMD, weighing modest BCVA gains against natural visual acuity variability, study quality concerns, and FDA authorization status.