MedTech News
.................... by Andrew Celentano
TransMedics Receives Full and Unconditional FDA IDE Approval for Next-Generation OCS Heart ENHANCE Trial
ANDOVER, Mass., Feb. 9, 2026 /PRNewswire/ — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of its Investigational Device Exemption (IDE) for the Next-Generation OCS ENHANCE Heart trial.
AI model can accelerate antibody drug production
Researchers detail a machine learning model that dramatically accelerates the manufacturing timeline of monoclonal antibodies.
AI algorithm enables tracking of brainstem’s vital white matter pathways
Research reveals distinct patterns of structural changes in patients with Parkinson’s disease, multiple sclerosis, and traumatic brain injury.
Simple patch can make medications safer and more effective
Researchers working alongside Australian diagnostics company Nutromics developed a minimally invasive patch that tracks the antibiotic in patients every five minutes.
Neurophet Secures FDA 510(k) Clearance for “Neurophet AQUA AD Plus,” Marking Its Third U.S. Regulatory Milestone
SEOUL, South Korea, Feb. 6, 2026 /PRNewswire/ — Neurophet (Co-CEOs Jake Junkil Been and Donghyeon Kim), an artificial intelligence (AI) solution company for brain disorders diagnosis and treatment, announced today that its software solution, Neurophet AQUA AD Plus, a comprehensive neuroimaging analysis solution for clinical evaluation related to Alzheimer’s disease, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
FDA grants clearance for Eyas Medical Imaging’s neonatal MRI system
Eyas Medical Imaging is currently scaling up operations with plans to commercialise the system in the US later this year.
Sonorous Neurovascular earns FDA breakthrough mark for novel stent
Sonorous Neurovascular received FDA breakthrough device designation for its BosSTENT device intended to treat pulsatile tinnitus, the company announced on Thursday.
Tiny ‘mini-me’ organs grown from children’s cells are transforming cystic fibrosis care
More than 2,000 known CFTR mutations have been identified worldwide. The type of mutation a patient carries can alter everything from how severe their symptoms are to what drugs will work for them.