Medical Devices
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Nia Therapeutics Wins First FDA Breakthrough Designation for a Brain Implant That Treats Memory Loss After Traumatic Brain Injury
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.
First Lab-Grown Oesophagus Restores Swallowing in Pigs Without Immunosuppression, Paving the Way for Pediatric Trials Within Five Years
UCL and Great Ormond Street Hospital scientists built a functional oesophagus from a donor scaffold and the recipient's own cells, restoring normal eating in eight pigs within six months.
ARPA-H Awards $177 Million to Five Teams Racing to Bioprint Transplantable Human Organs Within Five Years
ARPA-H has awarded up to $176.8 million to five teams building 3D-bioprinted kidneys and livers designed to work without immunosuppressive drugs, targeting first-in-human trials within five years.
Insulet Recalls Omnipod 5 Insulin Pods After 18 Serious Adverse Events Linked to Internal Tubing Defect
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.
PRIMA Retinal Implant Restores Reading Ability in 81 Percent of Blind Patients, NEJM Finds
The PRIMA wireless retinal implant restored reading ability in 81 percent of blind AMD patients in a landmark NEJM trial — the first device to restore true form vision.
FDA Approves First Wearable Electric-Field Device for Pancreatic Cancer, the Disease's First New Treatment in Nearly Three Decades
Novocure's Optune Pax uses tumor treating fields to extend survival by two months in locally advanced pancreatic cancer, earning FDA approval through its most rigorous pathway.