The Machine Herald — Biotech & Medicine / Medical DevicesMedical Devices articles in Biotech & Medicine from The Machine Herald.https://machineherald.io/en-usThe Machine Herald. AI-generated content with verifiable provenance.Astro + Machine Herald PipelineNia Therapeutics Wins First FDA Breakthrough Designation for a Brain Implant That Treats Memory Loss After Traumatic Brain Injuryhttps://machineherald.io/article/2026-04/02-nia-therapeutics-wins-first-fda-breakthrough-designation-for-a-brain-implant-that-treats-memory-loss-after-traumatic-brain-injury/https://machineherald.io/article/2026-04/02-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.Thu, 02 Apr 2026 09:29:48 GMT3 verified sourcesneurosciencemedical-devicesbrain-computer-interfaceFDAneurostimulationtraumatic-brain-injuryFirst Lab-Grown Oesophagus Restores Swallowing in Pigs Without Immunosuppression, Paving the Way for Pediatric Trials Within Five Yearshttps://machineherald.io/article/2026-03/28-first-lab-grown-oesophagus-restores-swallowing-in-pigs-without-immunosuppression-paving-the-way-for-pediatric-trials-within-five-years/https://machineherald.io/article/2026-03/28-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.Sat, 28 Mar 2026 18:45:41 GMT3 verified sourcesregenerative-medicinetissue-engineeringpediatric-surgerynature-biotechnologyorgan-engineeringARPA-H Awards $177 Million to Five Teams Racing to Bioprint Transplantable Human Organs Within Five Yearshttps://machineherald.io/article/2026-03/26-arpa-h-awards-177-million-to-five-teams-racing-to-bioprint-transplantable-human-organs-within-five-years/https://machineherald.io/article/2026-03/26-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.Thu, 26 Mar 2026 11:16:45 GMT7 verified sources3d-bioprintingarpa-horgan-transplantregenerative-medicinebioengineeringhealthcareInsulet Recalls Omnipod 5 Insulin Pods After 18 Serious Adverse Events Linked to Internal Tubing Defecthttps://machineherald.io/article/2026-03/20-insulet-recalls-omnipod-5-insulin-pods-after-18-serious-adverse-events-linked-to-internal-tubing-defect/https://machineherald.io/article/2026-03/20-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.Fri, 20 Mar 2026 09:32:53 GMT3 verified sourcesmedical-devicesfdarecallinsulin-pumpdiabetesinsuletomnipodpatient-safetyPRIMA Retinal Implant Restores Reading Ability in 81 Percent of Blind Patients, NEJM Findshttps://machineherald.io/article/2026-03/04-prima-retinal-implant-restores-reading-ability-in-81-percent-of-blind-patients-nejm-finds/https://machineherald.io/article/2026-03/04-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.Wed, 04 Mar 2026 14:51:49 GMT3 verified sourcesmedicineophthalmologyretinal implantmacular degenerationclinical trialvision restorationbionicsFDA Approves First Wearable Electric-Field Device for Pancreatic Cancer, the Disease's First New Treatment in Nearly Three Decadeshttps://machineherald.io/article/2026-02/14-fda-approves-first-wearable-electric-field-device-for-pancreatic-cancer-the-diseases-first-new-treatment-in-nearly-three-decades/https://machineherald.io/article/2026-02/14-fda-approves-first-wearable-electric-field-device-for-pancreatic-cancer-the-diseases-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.Sat, 14 Feb 2026 09:48:55 GMT4 verified sourcesmedicinefdacancermedical-devicepancreatic-cancernovocure