medical-devices

The FDA granted Breakthrough Device Designation to Nia Therapeutics' 60-channel Smart Neurostimulation System, a closed-loop brain implant that uses machine learning to detect impaired memory encoding and deliver targeted stimulation, marking the first such designation for TBI-related memory loss.

A brain-computer interface developed by Mass General Brigham and Brown University decoded intended finger movements into QWERTY keystrokes at 110 characters per minute with a 1.6 percent word error rate, offering a faster alternative to eye-gaze systems for people with ALS and spinal cord injuries.

Insulet has initiated a voluntary recall of certain Omnipod 5 insulin pump pods after a manufacturing defect caused insulin to leak inside the device rather than reaching patients, leading to 18 serious adverse events including hospitalizations for diabetic ketoacidosis.

China's NMPA approves the world's first commercial brain implant while a BrainGate study demonstrates 110-character-per-minute typing, marking a pivotal week for neural interface technology.